NCT03036150

Brief Summary

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
4,304

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2017

Typical duration for phase_3

Geographic Reach
21 countries

390 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 7, 2021

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

3.4 years

First QC Date

January 26, 2017

Results QC Date

April 19, 2021

Last Update Submit

June 15, 2021

Conditions

Keywords

Chronic Kidney Disease (CKD)Cardiovascular Events (CV)Phase III outcome trial

Outcome Measures

Primary Outcomes (1)

  • Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.

    End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR \<15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

    Up to 38.2 months

Secondary Outcomes (3)

  • Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.

    Up to 38.2 months

  • Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.

    Up to 38.2 months

  • Time to Death From Any Cause.

    Up to 38.2 months

Study Arms (2)

Dapagliflozin

EXPERIMENTAL

Patients will be randomized 1:1 to either dapagliflozin or placebo.

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo matching dapagliflozin.

Drug: Placebo

Interventions

10 mg or 5 mg tablets given once daily, per oral use.

Also known as: Forxiga TM, Farxiga TM
Dapagliflozin

Placebo matching dapagliflozin 10 mg or 5 mg

Placebo

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed informed consent prior to any study specific procedures
  • Female or male aged ≥18 years at the time of consent
  • eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
  • Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1
  • Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

You may not qualify if:

  • Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
  • Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
  • History of organ transplantation
  • Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
  • Type 1 diabetes mellitus
  • New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
  • MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (390)

Research Site

Birmingham, Alabama, 35233, United States

Location

Research Site

Hawaiian Gardens, California, 90716, United States

Location

Research Site

Lomita, California, 90717, United States

Location

Research Site

Los Angeles, California, 90022, United States

Location

Research Site

Palo Alto, California, 94304, United States

Location

Research Site

San Dimas, California, 91773, United States

Location

Research Site

San Ramon, California, 94582, United States

Location

Research Site

Vista, California, 92083, United States

Location

Research Site

Aurora, Colorado, 80045, United States

Location

Research Site

Denver, Colorado, 80246, United States

Location

Research Site

Boynton Beach, Florida, 33435, United States

Location

Research Site

Boynton Beach, Florida, 33472, United States

Location

Research Site

Jacksonville, Florida, 32224, United States

Location

Research Site

Miami, Florida, 33015, United States

Location

Research Site

Miami, Florida, 33144, United States

Location

Research Site

Miami, Florida, 33165, United States

Location

Research Site

Miami Lakes, Florida, 33014, United States

Location

Research Site

Naples, Florida, 34102, United States

Location

Research Site

New Port Richey, Florida, 34652, United States

Location

Research Site

Atlanta, Georgia, 30342-1797, United States

Location

Research Site

Augusta, Georgia, 30904, United States

Location

Research Site

Chicago, Illinois, 60643, United States

Location

Research Site

Iowa City, Iowa, 52242, United States

Location

Research Site

Topeka, Kansas, 66606, United States

Location

Research Site

Wichita, Kansas, 67214, United States

Location

Research Site

Metairie, Louisiana, 70006, United States

Location

Research Site

Boston, Massachusetts, 02111, United States

Location

Research Site

Detroit, Michigan, 48202, United States

Location

Research Site

Flint, Michigan, 48504, United States

Location

Research Site

Duluth, Minnesota, 55805, United States

Location

Research Site

Omaha, Nebraska, 68105, United States

Location

Research Site

Albany, New York, 12208, United States

Location

Research Site

Asheville, North Carolina, 28801, United States

Location

Research Site

Charlotte, North Carolina, 28207, United States

Location

Research Site

Hickory, North Carolina, 28601, United States

Location

Research Site

New Bern, North Carolina, 28562, United States

Location

Research Site

Winston-Salem, North Carolina, 27103, United States

Location

Research Site

Cincinnati, Ohio, 45219, United States

Location

Research Site

Maumee, Ohio, 43537, United States

Location

Research Site

Jersey Shore, Pennsylvania, 17740, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Greer, South Carolina, 29651, United States

Location

Research Site

Kingsport, Tennessee, 37660, United States

Location

Research Site

Nashville, Tennessee, 37232, United States

Location

Research Site

El Paso, Texas, 79935, United States

Location

Research Site

Fort Worth, Texas, 76116, United States

Location

Research Site

Fort Worth, Texas, 76117, United States

Location

Research Site

Fort Worth, Texas, 76164, United States

Location

Research Site

Houston, Texas, 77004, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Odessa, Texas, 79761, United States

Location

Research Site

Burke, Virginia, 22015, United States

Location

Research Site

Manassas, Virginia, 20110, United States

Location

Research Site

Newport News, Virginia, 23606, United States

Location

Research Site

Tacoma, Washington, 98405, United States

Location

Research Site

Buenos Aires, ARG 1425, Argentina

Location

Research Site

Buenos Aires, C1425BGN, Argentina

Location

Research Site

Buenos Aires, C1429BWN, Argentina

Location

Research Site

CABA, C1119ACN, Argentina

Location

Research Site

CABA, C1120AAC, Argentina

Location

Research Site

Ciudad Autonoma Buenos Aires, 1093, Argentina

Location

Research Site

Ciudad Autonoma de Buenos Aire, C1407GTN, Argentina

Location

Research Site

Corrientes, W3400AMZ, Argentina

Location

Research Site

Córdoba, 5000, Argentina

Location

Research Site

Córdoba, X5006CBI, Argentina

Location

Research Site

Córdoba, X5016LIG, Argentina

Location

Research Site

Mar del Plata, 7600, Argentina

Location

Research Site

Mar del Plata, B7600FZN, Argentina

Location

Research Site

Nueve de Julio, B6500EZL, Argentina

Location

Research Site

Rosario, S2000DEJ, Argentina

Location

Research Site

San Luis, D5700CTA, Argentina

Location

Research Site

San Miguel de Tucumán, 4000, Argentina

Location

Research Site

San Miguel de Tucumán, T4000ICL, Argentina

Location

Research Site

San Nicolás, B2900DMH, Argentina

Location

Research Site

Santa Fe, 3000, Argentina

Location

Research Site

Santa Rosa, 6300, Argentina

Location

Research Site

Botucatu, 18.618-686, Brazil

Location

Research Site

Campinas, 13010-001, Brazil

Location

Research Site

Caxias do Sul, 95070-560, Brazil

Location

Research Site

Curitiba, 80440-020, Brazil

Location

Research Site

Joinville, 89227-680, Brazil

Location

Research Site

Porto Alegre, 90020-090, Brazil

Location

Research Site

Porto Alegre, 90035-903, Brazil

Location

Research Site

Porto Alegre, 90610-000, Brazil

Location

Research Site

Salvador, 40415-065, Brazil

Location

Research Site

Santo André, 09090-790, Brazil

Location

Research Site

São José do Rio Preto, 15090-000, Brazil

Location

Research Site

São Paulo, 01228-000, Brazil

Location

Research Site

São Paulo, 04039-000, Brazil

Location

Research Site

São Paulo, 05403-000, Brazil

Location

Research Site

Edmonton, Alberta, T6H 2L4, Canada

Location

Research Site

Red Deer, Alberta, T4N 6V7, Canada

Location

Research Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Research Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Research Site

Brampton, Ontario, L6S 0C6, Canada

Location

Research Site

Concord, Ontario, L4K 4M2, Canada

Location

Research Site

Etobicoke, Ontario, M9R 4E1, Canada

Location

Research Site

Kingston, Ontario, K7L 2V7, Canada

Location

Research Site

London, Ontario, N6A 5A5, Canada

Location

Research Site

Oakville, Ontario, L6K 3V3, Canada

Location

Research Site

Oshawa, Ontario, L1G 2B9, Canada

Location

Research Site

Smiths Falls, Ontario, K7A 4W8, Canada

Location

Research Site

Toronto, Ontario, M4C 5T2, Canada

Location

Research Site

Toronto, Ontario, M5G 2N2, Canada

Location

Research Site

Chicoutimi, Quebec, G7H 7K9, Canada

Location

Research Site

Gatineau, Quebec, J8Y 6S8, Canada

Location

Research Site

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Research Site

Montreal, Quebec, H1T 2M4, Canada

Location

Research Site

Montreal, Quebec, H4J 1C5, Canada

Location

Research Site

Pointe-Claire, Quebec, H9R 3J1, Canada

Location

Research Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Research Site

Baotou, 14010, China

Location

Research Site

Beijing, 100034, China

Location

Research Site

Beijing, 100044, China

Location

Research Site

Beijing, 102206, China

Location

Research Site

Changchun, 130021, China

Location

Research Site

Changchun, 130041, China

Location

Research Site

Changsha, 410008, China

Location

Research Site

Chengdu, 610041, China

Location

Research Site

Chengdu, 610072, China

Location

Research Site

Foshan, 528000, China

Location

Research Site

Fuzhou, 350025, China

Location

Research Site

Guangzhou, 510000, China

Location

Research Site

Guangzhou, 510080, China

Location

Research Site

Guangzhou, 510515, China

Location

Research Site

Guiyang, 550004, China

Location

Research Site

Jilin, 132000, China

Location

Research Site

Lanzhou, 730030, China

Location

Research Site

Nanchang, 330006, China

Location

Research Site

Nanjin, 210029, China

Location

Research Site

Nanjing, 210009, China

Location

Research Site

Nanning, 530021, China

Location

Research Site

Ningbo, 315010, China

Location

Research Site

Shanghai, 200025, China

Location

Research Site

Shanghai, 200040, China

Location

Research Site

Shanghai, 200090, China

Location

Research Site

Shanghai, 200127, China

Location

Research Site

Shengyang, 110004, China

Location

Research Site

Shenzhen, 518053, China

Location

Research Site

Tianjin, 300052, China

Location

Research Site

Wuhan, 430033, China

Location

Research Site

Yinchuan, 750004, China

Location

Research Site

Yueyang, 414000, China

Location

Research Site

Aarhus, 8200, Denmark

Location

Research Site

Gentofte Municipality, 2820, Denmark

Location

Research Site

Herlev, 2730, Denmark

Location

Research Site

Hillerød, 3400, Denmark

Location

Research Site

København Ø, 2100, Denmark

Location

Research Site

Roskilde, 4000, Denmark

Location

Research Site

Aschaffenburg, 63739, Germany

Location

Research Site

Bad Oeynhausen, 32545, Germany

Location

Research Site

Berlin, 10117, Germany

Location

Research Site

Dresden, 01307, Germany

Location

Research Site

Düsseldorf, 40210, Germany

Location

Research Site

Essen, 45136, Germany

Location

Research Site

Frankfurt am Main, 60590, Germany

Location

Research Site

Hanover, 30625, Germany

Location

Research Site

Magdeburg, 39120, Germany

Location

Research Site

München, 81675, Germany

Location

Research Site

Münster, 48145, Germany

Location

Research Site

Schweinfurt, 97421, Germany

Location

Research Site

Tübingen, 72076, Germany

Location

Research Site

Ulm, 89081, Germany

Location

Research Site

Budapest, 1083, Hungary

Location

Research Site

Budapest, 1096, Hungary

Location

Research Site

Budapest, 1106, Hungary

Location

Research Site

Budapest, 1212, Hungary

Location

Research Site

Eger, 3300, Hungary

Location

Research Site

Gyula, 5700, Hungary

Location

Research Site

Kistarcsa, 2143, Hungary

Location

Research Site

Miskolc, 3526, Hungary

Location

Research Site

Nyíregyháza, 4400, Hungary

Location

Research Site

Pécs, 7624, Hungary

Location

Research Site

Szeged, 6720, Hungary

Location

Research Site

Velence, 2481, Hungary

Location

Research Site

Ahmedabad, 380016, India

Location

Research Site

Bangalore, 560002, India

Location

Research Site

Calicut, 673008, India

Location

Research Site

Chennai, 600001, India

Location

Research Site

Ernākulam, 683594, India

Location

Research Site

Hyderabad, 500018, India

Location

Research Site

Kanpur, 208002, India

Location

Research Site

Kolkata, 700020, India

Location

Research Site

Lucknow, 226003, India

Location

Research Site

Lucknow, 226005, India

Location

Research Site

Madurai, 625020, India

Location

Research Site

Maharashtra, 411013, India

Location

Research Site

Mangalore, 575003, India

Location

Research Site

Nagpur, 440003, India

Location

Research Site

Nagpur, 440012, India

Location

Research Site

New Delhi, 110017, India

Location

Research Site

Pune, 411001, India

Location

Research Site

Pune, 411040, India

Location

Research Site

Vijayawada, 522002, India

Location

Research Site

Amagasaki-shi, 660-8550, Japan

Location

Research Site

Asahikawa-shi, 070-8644, Japan

Location

Research Site

Beppu-shi, 874-0011, Japan

Location

Research Site

Bunkyō City, 113-8431, Japan

Location

Research Site

Chiba, 260-8712, Japan

Location

Research Site

Chūōku, 103-0002, Japan

Location

Research Site

Chūōku, 103-0027, Japan

Location

Research Site

Chūōku, 104-0031, Japan

Location

Research Site

Daito-shi, 574-0074, Japan

Location

Research Site

Fujisawa-shi, 251-8550, Japan

Location

Research Site

Fukuoka, 810-0065, Japan

Location

Research Site

Higashiibaraki-gun, 311-3193, Japan

Location

Research Site

Iizuka-shi, 820-8505, Japan

Location

Research Site

Itabashi-ku, 173-8610, Japan

Location

Research Site

Kamakura-shi, 247-8533, Japan

Location

Research Site

Kanazawa, 920-8650, Japan

Location

Research Site

Kawachinagano-shi, 586-8521, Japan

Location

Research Site

Kawasaki-shi, 211-8510, Japan

Location

Research Site

Kobe, 654-0155, Japan

Location

Research Site

Koga-shi, 811-3195, Japan

Location

Research Site

Koshigaya-shi, 343-8577, Japan

Location

Research Site

Kumamoto, 860-0008, Japan

Location

Research Site

Kurashiki, 701 0192, Japan

Location

Research Site

Matsumoto-shi, 390-8621, Japan

Location

Research Site

Nagano, 388-8004, Japan

Location

Research Site

Nagoya, 455-8530, Japan

Location

Research Site

Nagoya, 456-0058, Japan

Location

Research Site

Nagoya, 457-8511, Japan

Location

Research Site

Naha, 902-0061, Japan

Location

Research Site

Neyagawa, 572-0015, Japan

Location

Research Site

Niigata, 951-8520, Japan

Location

Research Site

Okayama, 700-8558, Japan

Location

Research Site

Okayama, 701-1192, Japan

Location

Research Site

Osaka, 530-8480, Japan

Location

Research Site

Osaka, 540-0006, Japan

Location

Research Site

Osaka, 558-8558, Japan

Location

Research Site

Ōita, 870-0039, Japan

Location

Research Site

Saga, 840-8571, Japan

Location

Research Site

Sapporo, 063-0005, Japan

Location

Research Site

Shizuoka, 420-8630, Japan

Location

Research Site

Takarazuka-shi, 665-0861, Japan

Location

Research Site

Toride-shi, 302-0022, Japan

Location

Research Site

Tsu, 514-1101, Japan

Location

Research Site

Tsu, 514-8507, Japan

Location

Research Site

Tsuchiura-shi, 300-0028, Japan

Location

Research Site

Ueda-shi, 386-8610, Japan

Location

Research Site

Uji-shi, 611-0041, Japan

Location

Research Site

Yaizu-shi, 425-8505, Japan

Location

Research Site

Yokohama, 232-0024, Japan

Location

Research Site

Aguascalientes, 20230, Mexico

Location

Research Site

Cuernavaca, 62448, Mexico

Location

Research Site

Culiacán, 80230, Mexico

Location

Research Site

D.F, 14000, Mexico

Location

Research Site

Durango, 34000, Mexico

Location

Research Site

Guadalajara, 44600, Mexico

Location

Research Site

Mazatlán, 82000, Mexico

Location

Research Site

Mazatlán, 82110, Mexico

Location

Research Site

México, 06700, Mexico

Location

Research Site

México, 06726, Mexico

Location

Research Site

México, 14080, Mexico

Location

Research Site

Minatitlán, 96730, Mexico

Location

Research Site

Monterrey, 64060, Mexico

Location

Research Site

Monterrey, 64460, Mexico

Location

Research Site

Saltillo, 25230, Mexico

Location

Research Site

Arequipa, AREQUIPA01, Peru

Location

Research Site

Callao, CALLAO 2, Peru

Location

Research Site

Chorrillos, Lima 9, Peru

Location

Research Site

Cusco, CUSCO 01, Peru

Location

Research Site

Ica, Peru

Location

Research Site

Lima, 14, Peru

Location

Research Site

Lima, 36, Peru

Location

Research Site

Lima, L27, Peru

Location

Research Site

Lima, LIMA 01, Peru

Location

Research Site

Lima, LIMA 1, Peru

Location

Research Site

Lima, LIMA 27, Peru

Location

Research Site

Lima, LIMA 31, Peru

Location

Research Site

Piura, Peru

Location

Research Site

San Isidro, Lima 27, Peru

Location

Research Site

San Miguel, Lima 32, Peru

Location

Research Site

Bacolod, 6100, Philippines

Location

Research Site

Cebu, 6000, Philippines

Location

Research Site

Cebu City, 6000, Philippines

Location

Research Site

Dasmariñas, 4114, Philippines

Location

Research Site

Davao City, PH-8000, Philippines

Location

Research Site

Iloilo City, 5000, Philippines

Location

Research Site

Makati City, 1218, Philippines

Location

Research Site

Marikina City, 1800, Philippines

Location

Research Site

Quezon City, 1101, Philippines

Location

Research Site

Bielsko-Biala, 43-300, Poland

Location

Research Site

Bochnia, 32-700, Poland

Location

Research Site

Chorzów, 41-500, Poland

Location

Research Site

Ciechanów, 06-400, Poland

Location

Research Site

Katowice, 40-081, Poland

Location

Research Site

Katowice, 40-648, Poland

Location

Research Site

Krakow, 31-156, Poland

Location

Research Site

Krakow, 31-530, Poland

Location

Research Site

Legnica, 59-220, Poland

Location

Research Site

Lodz, 92-213, Poland

Location

Research Site

Olsztyn, 10-561, Poland

Location

Research Site

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Research Site

Oława, 55-200, Poland

Location

Research Site

Poznan, 60-821, Poland

Location

Research Site

Ruda Śląska, 41-709, Poland

Location

Research Site

Rzeszów, 35-055, Poland

Location

Research Site

Szczecin, 70-111, Poland

Location

Research Site

Tczew, 83-110, Poland

Location

Research Site

Chelyabinsk, 454091, Russia

Location

Research Site

Kazan', 420012, Russia

Location

Research Site

Kemerovo, 650002, Russia

Location

Research Site

Kemerovo, 650066, Russia

Location

Research Site

Krasnoyarsk, 660062, Russia

Location

Research Site

Moscow, 123995, Russia

Location

Research Site

Omsk, 644112, Russia

Location

Research Site

Perm, 614000, Russia

Location

Research Site

Perm, 614068, Russia

Location

Research Site

Rostov-on-Don, 344022, Russia

Location

Research Site

Saint Petersburg, 194354, Russia

Location

Research Site

Saint Petersburg, 196601, Russia

Location

Research Site

Saint Petersburg, 199106, Russia

Location

Research Site

Saratov, 410053, Russia

Location

Research Site

Tver', 170036, Russia

Location

Research Site

Ufa, 450071, Russia

Location

Research Site

Vladikavkaz, 362007, Russia

Location

Research Site

Volgograd, 400131, Russia

Location

Research Site

Yaroslavl, 150062, Russia

Location

Research Site

Yekaterinburg, 620039, Russia

Location

Research Site

Ansan-si, 15355, South Korea

Location

Research Site

Deagu, 41944, South Korea

Location

Research Site

Goyang-si, 10380, South Korea

Location

Research Site

Goyang-si, 10444, South Korea

Location

Research Site

Gwangju, 61469, South Korea

Location

Research Site

Jeonju, 54907, South Korea

Location

Research Site

Seongnam-si, 13620, South Korea

Location

Research Site

Seoul, 03080, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 06273, South Korea

Location

Research Site

Seoul, 06591, South Korea

Location

Research Site

Seoul, 07061, South Korea

Location

Research Site

Seoul, 07804, South Korea

Location

Research Site

Seoul, 07985, South Korea

Location

Research Site

Uijeongbu-si, 11765, South Korea

Location

Research Site

Wŏnju, 26426, South Korea

Location

Research Site

A Coruña, 15006, Spain

Location

Research Site

Barcelona, 08003, Spain

Location

Research Site

Barcelona, 08035, Spain

Location

Research Site

Burela (Lugo), 27880, Spain

Location

Research Site

L'Hospitalet de Llobregat, 08907, Spain

Location

Research Site

Madrid, 28041, Spain

Location

Research Site

Málaga, 29010, Spain

Location

Research Site

Santiago de Compostela, 15706, Spain

Location

Research Site

Seville, 41071, Spain

Location

Research Site

Valencia, 46010, Spain

Location

Research Site

Valencia, 46017, Spain

Location

Research Site

Gothenburg, 413 45, Sweden

Location

Research Site

Malmo, 205 02, Sweden

Location

Research Site

Stockholm, 141 86, Sweden

Location

Research Site

Stockholm, 182 88, Sweden

Location

Research Site

Uppsala, 751 85, Sweden

Location

Research Site

Cherkasy, 18009, Ukraine

Location

Research Site

Chernivtsі, 58018, Ukraine

Location

Research Site

Dnipro, 49005, Ukraine

Location

Research Site

Dnipro, 49102, Ukraine

Location

Research Site

Ivano-Frankivsk, 76008, Ukraine

Location

Research Site

Ivano-Frankivsk, 76018, Ukraine

Location

Research Site

Kharkiv Region, 61039, Ukraine

Location

Research Site

Kharkiv Region, 61103, Ukraine

Location

Research Site

Kharkiv Region, 61166, Ukraine

Location

Research Site

Kyiv, 02091, Ukraine

Location

Research Site

Kyiv, 02125, Ukraine

Location

Research Site

Kyiv, 04053, Ukraine

Location

Research Site

Kyiv, 4050, Ukraine

Location

Research Site

Lutsk, 43005, Ukraine

Location

Research Site

Odesa, 65025, Ukraine

Location

Research Site

Poltava, 36011, Ukraine

Location

Research Site

Rivne, 33027, Ukraine

Location

Research Site

Ternopil, 46000, Ukraine

Location

Research Site

Vinnytsia, 21001, Ukraine

Location

Research Site

Vinnytsia, 21018, Ukraine

Location

Research Site

Zaporizhzhia, 69600, Ukraine

Location

Research Site

Cardiff, CF14 4XW, United Kingdom

Location

Research Site

Glasgow, G51 4TF, United Kingdom

Location

Research Site

Hull, HU3 2JZ, United Kingdom

Location

Research Site

Kent, BR6 8ND, United Kingdom

Location

Research Site

Leicester, LE5 4PW, United Kingdom

Location

Research Site

London, E1 1BB, United Kingdom

Location

Research Site

London, SE5 9RS, United Kingdom

Location

Research Site

Salford, M6 8HD, United Kingdom

Location

Research Site

Swansea, SA6 6NL, United Kingdom

Location

Research Site

Biên Hòa, 810000, Vietnam

Location

Research Site

Hanoi, 10000, Vietnam

Location

Research Site

Ho Chi Minh City, 10000, Vietnam

Location

Research Site

Ho Chi Minh City, 7000000, Vietnam

Location

Research Site

Ho Chi Minh City, 700000, Vietnam

Location

Research Site

Ho Chi Minh City, 70000, Vietnam

Location

Research Site

Ho Chi Minh City, 9000, Vietnam

Location

Research Site

Hochiminh, 700000, Vietnam

Location

Related Publications (32)

  • Heerspink HJL, Chertow GM, Rossing P, Correa-Rotter R, Sjostrom CD, Toto RD, Wheeler DC, Jongs N. Effects of Dapagliflozin on Progression of CKD According to Different Rates of Pretrial eGFR Loss. Clin J Am Soc Nephrol. 2025 Nov 1;20(11):1527-1535. doi: 10.2215/CJN.0000000810. Epub 2025 Sep 9.

  • Bakker WM, Heerspink HJL, Jongs N, Correa-Rotter R, Rossing P, Toto RD, Wheeler DC, McMurray JJV, Langkilde AM, Gansevoort RT, Chertow GM, Vart P. Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD. J Am Soc Nephrol. 2026 Jan 1;37(1):101-109. doi: 10.1681/ASN.0000000776. Epub 2025 Jul 18.

  • Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.

  • Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.

  • van Mil D, Vart P, Chertow GM, Gansevoort RT, Rossing P, Toto RD, Correa-Rotter R, Langkilde AM, Sjostrom CD, Wheeler DC, Heerspink HJL. Baseline, Early Changes, and Residual Albuminuria: Post Hoc Analysis of a Randomized Clinical Trial of Dapagliflozin in Chronic Kidney Disease. Clin J Am Soc Nephrol. 2024 Dec 1;19(12):1574-1584. doi: 10.2215/CJN.0000000000000550.

  • Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.

  • Zhang Z, Heerspink HJL, Chertow GM, Correa-Rotter R, Gasparrini A, Jongs N, Langkilde AM, McMurray JJV, Mistry MN, Rossing P, Toto RD, Vart P, Nitsch D, Wheeler DC, Caplin B. Ambient heat exposure and kidney function in patients with chronic kidney disease: a post-hoc analysis of the DAPA-CKD trial. Lancet Planet Health. 2024 Apr;8(4):e225-e233. doi: 10.1016/S2542-5196(24)00026-3.

  • Heerspink HJL, Stack AG, Terkeltaub R, Jongs N, Inker LA, Bjursell M, Maklad N, Perl S, Eklund O, Rikte T, Sjostrom CD, Perkovic V; SAPPHIRE Investigators. Combination Treatment with Verinurad and Allopurinol in CKD: A Randomized Placebo and Active Controlled Trial. J Am Soc Nephrol. 2024 May 1;35(5):594-606. doi: 10.1681/ASN.0000000000000326. Epub 2024 Feb 20.

  • Koshino A, Schechter M, Chertow GM, Vart P, Jongs N, Toto RD, Rossing P, Correa-Rotter R, McMurray JJV, Gorriz JL, Isidto R, Kashihara N, Langkilde AM, Wheeler DC, Heerspink HJL. Dapagliflozin and Anemia in Patients with Chronic Kidney Disease. NEJM Evid. 2023 Jun;2(6):EVIDoa2300049. doi: 10.1056/EVIDoa2300049. Epub 2023 May 19.

  • Yu MK, Vart P, Jongs N, Correa-Rotter R, Rossing P, McMurray JJV, Hou FF, Douthat W, Khullar D, Langkilde AM, Wheeler DC, Heerspink HJL, Chertow GM. Effects of Dapagliflozin in Chronic Kidney Disease Across the Spectrum of Age and by Sex. J Gen Intern Med. 2024 May;39(6):921-930. doi: 10.1007/s11606-023-08397-9. Epub 2023 Dec 14.

  • Fletcher RA, Jongs N, Chertow GM, McMurray JJV, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Rockenschaub P, Rossing P, Correa-Rotter R, Toto RD, Vaduganathan M, Wheeler DC, Heerspink HJL, Neuen BL. Effect of SGLT2 Inhibitors on Discontinuation of Renin-angiotensin System Blockade: A Joint Analysis of the CREDENCE and DAPA-CKD Trials. J Am Soc Nephrol. 2023 Dec 1;34(12):1965-1975. doi: 10.1681/ASN.0000000000000248. Epub 2023 Oct 25.

  • Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.

  • Chertow GM, Correa-Rotter R, Vart P, Jongs N, McMurray JJV, Rossing P, Langkilde AM, Sjostrom CD, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of Dapagliflozin in Chronic Kidney Disease, With and Without Other Cardiovascular Medications: DAPA-CKD Trial. J Am Heart Assoc. 2023 May 2;12(9):e028739. doi: 10.1161/JAHA.122.028739. Epub 2023 Apr 29.

  • Vart P, Jongs N, Wheeler DC, Heerspink HJL, Langkilde AM, Chertow GM. Effectiveness and Safety of Dapagliflozin for Black vs White Patients With Chronic Kidney Disease in North and South America: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e2310877. doi: 10.1001/jamanetworkopen.2023.10877.

  • Willigers BJA, Ouwens M, Briggs A, Heerspink HJL, Pollock C, Pecoits-Filho R, Tangri N, Kovesdy CP, Wheeler DC, Garcia Sanchez JJ. The Role of Expert Opinion in Projecting Long-Term Survival Outcomes Beyond the Horizon of a Clinical Trial. Adv Ther. 2023 Jun;40(6):2741-2751. doi: 10.1007/s12325-023-02503-3. Epub 2023 Apr 18.

  • Schechter M, Jongs N, Chertow GM, Mosenzon O, McMurray JJV, Correa-Rotter R, Rossing P, Langkilde AM, Sjostrom CD, Toto RD, Wheeler DC, Heerspink HJL. Effects of Dapagliflozin on Hospitalizations in Patients With Chronic Kidney Disease : A Post Hoc Analysis of DAPA-CKD. Ann Intern Med. 2023 Jan;176(1):59-66. doi: 10.7326/M22-2115. Epub 2022 Dec 6.

  • Vart P, Vaduganathan M, Jongs N, Remuzzi G, Wheeler DC, Hou FF, McCausland F, Chertow GM, Heerspink HJL. Estimated Lifetime Benefit of Combined RAAS and SGLT2 Inhibitor Therapy in Patients with Albuminuric CKD without Diabetes. Clin J Am Soc Nephrol. 2022 Dec;17(12):1754-1762. doi: 10.2215/CJN.08900722. Epub 2022 Nov 22.

  • McEwan P, Darlington O, Miller R, McMurray JJV, Wheeler DC, Heerspink HJL, Briggs A, Bergenheim K, Garcia Sanchez JJ. Cost-Effectiveness of Dapagliflozin as a Treatment for Chronic Kidney Disease: A Health-Economic Analysis of DAPA-CKD. Clin J Am Soc Nephrol. 2022 Dec;17(12):1730-1741. doi: 10.2215/CJN.03790322. Epub 2022 Nov 2.

  • Jongs N, Chertow GM, Greene T, McMurray JJV, Langkilde AM, Correa-Rotter R, Kashihara N, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators; Members of the DAPA-CKD Trial Committees and Investigators. Correlates and Consequences of an Acute Change in eGFR in Response to the SGLT2 Inhibitor Dapagliflozin in Patients with CKD. J Am Soc Nephrol. 2022 Nov;33(11):2094-2107. doi: 10.1681/ASN.2022030306. Epub 2022 Aug 17.

  • Vart P, Correa-Rotter R, Hou FF, Jongs N, Chertow GM, Langkilde AM, McMurray JJV, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Douthat W, Escudero E, Isidto R, Khullar D, Bajaj HS, Wheeler DC, Heerspink HJL. Efficacy and Safety of Dapagliflozin in Patients With CKD Across Major Geographic Regions. Kidney Int Rep. 2022 Feb 2;7(4):699-707. doi: 10.1016/j.ekir.2022.01.1060. eCollection 2022 Apr.

  • Waijer SW, Vart P, Cherney DZI, Chertow GM, Jongs N, Langkilde AM, Mann JFE, Mosenzon O, McMurray JJV, Rossing P, Correa-Rotter R, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL. Effect of dapagliflozin on kidney and cardiovascular outcomes by baseline KDIGO risk categories: a post hoc analysis of the DAPA-CKD trial. Diabetologia. 2022 Jul;65(7):1085-1097. doi: 10.1007/s00125-022-05694-6. Epub 2022 Apr 21.

  • Heerspink HJL, Jongs N, Chertow GM, Langkilde AM, McMurray JJV, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Greene T; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on the rate of decline in kidney function in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):743-754. doi: 10.1016/S2213-8587(21)00242-4. Epub 2021 Oct 4.

  • Jongs N, Greene T, Chertow GM, McMurray JJV, Langkilde AM, Correa-Rotter R, Rossing P, Sjostrom CD, Stefansson BV, Toto RD, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effect of dapagliflozin on urinary albumin excretion in patients with chronic kidney disease with and without type 2 diabetes: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Nov;9(11):755-766. doi: 10.1016/S2213-8587(21)00243-6. Epub 2021 Oct 4.

  • McMurray JJV, Wheeler DC, Stefansson BV, Jongs N, Postmus D, Correa-Rotter R, Chertow GM, Hou FF, Rossing P, Sjostrom CD, Solomon SD, Toto RD, Langkilde AM, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of Dapagliflozin in Patients With Kidney Disease, With and Without Heart Failure. JACC Heart Fail. 2021 Nov;9(11):807-820. doi: 10.1016/j.jchf.2021.06.017. Epub 2021 Aug 23.

  • Persson F, Rossing P, Vart P, Chertow GM, Hou FF, Jongs N, McMurray JJV, Correa-Rotter R, Bajaj HS, Stefansson BV, Toto RD, Langkilde AM, Wheeler DC, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial. Diabetes Care. 2021 Aug;44(8):1894-1897. doi: 10.2337/dc21-0300. Epub 2021 Jun 28.

  • Wheeler DC, Stefansson BV, Jongs N, Chertow GM, Greene T, Hou FF, McMurray JJV, Correa-Rotter R, Rossing P, Toto RD, Sjostrom CD, Langkilde AM, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effects of dapagliflozin on major adverse kidney and cardiovascular events in patients with diabetic and non-diabetic chronic kidney disease: a prespecified analysis from the DAPA-CKD trial. Lancet Diabetes Endocrinol. 2021 Jan;9(1):22-31. doi: 10.1016/S2213-8587(20)30369-7.

  • McMurray JJV, Wheeler DC, Stefansson BV, Jongs N, Postmus D, Correa-Rotter R, Chertow GM, Greene T, Held C, Hou FF, Mann JFE, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Heerspink HJL; DAPA-CKD Trial Committees and Investigators. Effect of Dapagliflozin on Clinical Outcomes in Patients With Chronic Kidney Disease, With and Without Cardiovascular Disease. Circulation. 2021 Feb 2;143(5):438-448. doi: 10.1161/CIRCULATIONAHA.120.051675. Epub 2020 Nov 13.

  • Heerspink HJL, Stefansson BV, Correa-Rotter R, Chertow GM, Greene T, Hou FF, Mann JFE, McMurray JJV, Lindberg M, Rossing P, Sjostrom CD, Toto RD, Langkilde AM, Wheeler DC; DAPA-CKD Trial Committees and Investigators. Dapagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2020 Oct 8;383(15):1436-1446. doi: 10.1056/NEJMoa2024816. Epub 2020 Sep 24.

  • Wheeler DC, Stefansson BV, Batiushin M, Bilchenko O, Cherney DZI, Chertow GM, Douthat W, Dwyer JP, Escudero E, Pecoits-Filho R, Furuland H, Gorriz JL, Greene T, Haller H, Hou FF, Kang SW, Isidto R, Khullar D, Mark PB, McMurray JJV, Kashihara N, Nowicki M, Persson F, Correa-Rotter R, Rossing P, Toto RD, Umanath K, Van Bui P, Wittmann I, Lindberg M, Sjostrom CD, Langkilde AM, Heerspink HJL. The dapagliflozin and prevention of adverse outcomes in chronic kidney disease (DAPA-CKD) trial: baseline characteristics. Nephrol Dial Transplant. 2020 Oct 1;35(10):1700-1711. doi: 10.1093/ndt/gfaa234.

  • Piperidou A, Loutradis C, Sarafidis P. SGLT-2 inhibitors and nephroprotection: current evidence and future perspectives. J Hum Hypertens. 2021 Jan;35(1):12-25. doi: 10.1038/s41371-020-00393-4. Epub 2020 Aug 10.

  • Sternlicht HK, Bakris GL. Reductions in albuminuria with SGLT2 inhibitors: a marker for improved renal outcomes in patients without diabetes? Lancet Diabetes Endocrinol. 2020 Jul;8(7):553-555. doi: 10.1016/S2213-8587(20)30185-6. No abstract available.

  • Gonzalez DE, Foresto RD, Ribeiro AB. SGLT-2 inhibitors in diabetes: a focus on renoprotection. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s17-s24. doi: 10.1590/1806-9282.66.S1.17.

Related Links

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
AstraZeneca Clinical Study Information Center
Organization
AstraZeneca

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2017

First Posted

January 30, 2017

Study Start

February 2, 2017

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

July 7, 2021

Results First Posted

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations