Efficacy and Safety of KBP-5074 in Uncontrolled Hypertension and Moderate or Severe Chronic Kidney Disease (CKD)

NCT04968184 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: KBP5074-3-001
• Study Type: interventional
• Target: 652
• Locations: 22 countries
• Sites: 215

Brief Summary

This Phase 3, randomized, Double-blind, placebo-controlled, 2-arm, parallel-group, multicenter study with randomized withdrawal will evaluate the efficacy, safety, and durability of KBP-5074 in adult participants who have stage 3b/4 chronic kidney disease (CKD) (estimated glomerular filtration rate \[eGFR\] calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula \[eGFR {EPI}\] ≥15 to ≤44 mL/min/1.73 m\^2) and uncontrolled hypertension (systolic blood pressure (SBP) ≥140 and \<180 mm Hg and taking 2 or more antihypertensive medications.

Conditions

Chronic Kidney Diseases

Keywords

Stage 3b/4 chronic kidney disease; Hypertension; Uncontrolled Hypertension; Blood pressure; Mineralocorticoid Receptor Antagonist; Randomized withdrawal

Outcome Measures

Primary Outcomes (2)

• Change in seated trough cuff SBP from baseline to Week 12

  Efficacy of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for KBP-5074 dose regimen compared to placebo, will be evaluated.

  From baseline to Week 12

• Change in seated trough cuff SBP from Week 48 to Week 52

  Durability of KBP-5074 in reducing SBP by assessing change in seated trough cuff SBP for the KBP-5074 dose regimen compared to placebo, will be evaluated.

  Week 48 to Week 52

Secondary Outcomes (11)

• Change in seated trough cuff SBP from baseline to Week 24

  From baseline to Week 24

• Changes in seated trough cuff diastolic blood pressure (DBP) from baseline to Week 12 and Week 24

  From baseline to Week 12 and Week 24

• Changes in seated trough cuff SBP and DBP from baseline to Week 48

  From baseline to Week 48

• Changes in urinary albumin: creatinine ratio (UACR) from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline

  From baseline to Week 12 and Week 24

• Percentage changes in UACR from baseline to Week 12 and Week 24 for participants with UACR ≥30 mg/g at baseline

  From baseline to Week 12 and Week 24

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Open-label Placebo Run-In Period: All eligible participants will receive matching placebo, for approximately 2 weeks, during the Open-label placebo Run-In period. Double-blind Treatment Period: All eligible participants will receive matching placebo, from week 2 thru week 24 during the Double-blind treatment Period Open-label Treatment Period: All eligible participants will receive KBP-5074, from week 24 thru week 48 during the Open label Treatment Period Randomized Double-blind Withdrawal Period: All eligible participants will be randomized to either continue their current KBP-5074 dose at the end of the Open-Label Treatment Period or receive matching placebo from week 48 thru week 52. Follow up Period: All participants will discontinue matching placebo/KBP-5074 and be followed for safety until end of study visit from week 52 to week 56.

Drug: Placebo

KBP-5074

EXPERIMENTAL

Open-label Placebo Run-In period: All eligible participants will receive matching placebo, for approximately 2 weeks during the Open-label placebo Run-In period. Double-blind Treatment Period: All eligible participants will receive KBP-5074, from week 2 thru week 24 during the Double-blind Treatment Period Open-label Treatment Period: All eligible participants will receive KBP-5074, from week 24 thru week 48 during the Open label Treatment Period Randomized Double-blind Withdrawal Period: All eligible participants will be randomized to either continue their current KBP-5074 dose at the end of the Open-Label Treatment Period or receive matching placebo from week 48 thru week 52. Follow up Period: All participants will discontinue matching placebo/KBP-5074 and be followed for safety until end of study visit from week 52 to week 56.

Drug: KBP-5074

Interventions

Placebo DRUG

Participants will orally receive placebo matching to KBP-5074 tablets QD.

Placebo

KBP-5074 DRUG

Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.

KBP-5074

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) must be ≥19 to \<45 kg/m\^2 at the Screening Visit
• Participant must have uncontrolled hypertension defined as meeting both of the following criteria:
• The participant has a resting seated trough cuff SBP ≥140 mm Hg at the Screening Visit (Visit 1), and at the start (Visit 2) and end (Visit 3) of the Run-In Period
• The participant is taking 2 or more antihypertensive medications that have been titrated upward as tolerated to hypertension target doses per local SoC and have been stable (i.e., without any dose adjustments) from 4 weeks before the Screening Visit (Visit 1) through the end of the Run-In Period (Visit 3)
• The participant must have Stage 3b (eGFR \[EPI\] ≥30 and ≤44 mL/min/1.73 m\^2) or Stage 4 (eGFR \[EPI\] ≥15 and \<30 mL/min/1.73 m\^2) CKD.

You may not qualify if:

• Participant has a resting seated trough cuff SBP ≥180 mm Hg at the Screening Visit (Visit 1) or at the start (Visit 2) or end (Visit 3) of the Run-In Period
• Participant has a serum potassium level \>4.8 mmol/L during the Screening or Run-In Periods
• Participant has had a serum potassium level \>5.6 mmol/L within 2 weeks before the Screening Visit (Visit 1)
• Participant has been hospitalized for hyperkalemia within the 3 months before the Randomization Visit (Visit 3)
• Participant was not compliant with taking placebo during the Run-in Period or participant was not compliant with background antihypertensive medications during the Run-in Period as assessed at the Randomization Visit (Visit 3)
• Participant has taken an mineralocorticoid receptor antagonist (MRA), a potassium-sparing diuretic, or chronic potassium supplements during the 4 weeks before the Screening Visit (Visit 1)
• Participant has taken potassium binders for the treatment of hyperkalemia during the 3 months before the Screening Visit (Visit 1)
• Participant has taken a strong cytochrome P450 (CYP) CYP3A4 inducer or strong CYP3A4 inhibitor during the 7 days before the Randomization Visit (Visit 3)
• Participant has taken a prohibited traditional Chinese medication during the 28 days prior to Screening Visit (Visit 1).
• Participant was administered any other investigational product within 4 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit (Visit 1).

Sponsors & Collaborators

• KBP Biosciences: lead

Study Sites (215)

G & L Research, LLC

Foley, Alabama, 36535, United States

Location

Apogee Clinical Research, LLC

Huntsville, Alabama, 35805, United States

Location

Aventiv Research, Inc

Mesa, Arizona, 85210, United States

Location

National Heart Institute

Beverly Hills, California, 90211-2285, United States

Location

Amicis Research Center (Valencia)

Granada Hills, California, 91324, United States

Location

Amicis Research Center

Granada Hills, California, 91344, United States

Location

Amicis Research Center

Lancaster, California, 93534, United States

Location

Renal Consultants Medical Group - Granada Hills

Northridge, California, 91325, United States

Location

United Clinical Research and Innovations

South Gate, California, 90280, United States

Location

Solano Kidney Care

Vacaville, California, 95687-3557, United States

Location

Desert Cities Dialysis - Amethyst

Victorville, California, 92392, United States

Location

Kidney and Hypertension Center

Victorville, California, 92395, United States

Location

Davita Clinical Research-Hartford

Bloomfield, Connecticut, 06002, United States

Location

Synergy Healthcare

Bradenton, Florida, 34208, United States

Location

Homestead Associates in Research, Inc

Miami, Florida, 33032-8225, United States

Location

Total Research Group

Miami, Florida, 33126-3422, United States

Location

LCC Medical Research

Miami, Florida, 33126, United States

Location

Oceane 7 Medical&Research Center, Inc.

Miami, Florida, 33144, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

South Florida Research Phase I-Iv, Inc.

Miami, Florida, 33166, United States

Location

San Marcus Research Clinic, Inc.

Miami Lakes, Florida, 33014-5602, United States

Location

Inpatient Research Clinic, LLC

Miami Lakes, Florida, 33014, United States

Location

New Generation Of Medical Research

Naples, Florida, 34104, United States

Location

Sarkis Clinical

Ocala, Florida, 34471, United States

Location

Omega Research Orlando, LLC

Orlando, Florida, 32808, United States

Location

Genesis Clinical Research

Tampa, Florida, 33603, United States

Location

Santos Research Center CORP

Tampa, Florida, 33604, United States

Location

Fides Clinical Research

Atlanta, Georgia, 30342, United States

Location

Southeastern Clinical Research Institute, LLC

Augusta, Georgia, 30904, United States

Location

Columbus Associates LLC

Columbus, Georgia, 31904-3650, United States

Location

Central Georgia Kidney Specialists

Macon, Georgia, 31201-6863, United States

Location

Clinical Investigation Specialists, Inc.

Gurney, Illinois, 60031, United States

Location

Massachusetts General Hospital (MGH) - Renal Associates Clinic

Boston, Massachusetts, 02114, United States

Location

InterMed Consultants

Edina, Minnesota, 55435-2129, United States

Location

Healthcare Research Network

Hazelwood, Missouri, 63042, United States

Location

Clinical Research Consultants

Kansas City, Missouri, 64111-5964, United States

Location

St. Louis Heart and Vascular, P.C. (SLHV) - Christian Hospital Office

St Louis, Missouri, 63136-6111, United States

Location

Healor Primary Care /CCT Research

Las Vegas, Nevada, 89102-1682, United States

Location

DaVita Clinical Research (Nevada)

Las Vegas, Nevada, 89128, United States

Location

NYC Health + Hospitals / Queens - Diabetes Center of Excellence

Jamaica, New York, 11432, United States

Location

Mattoo & Bhat Medical Associates, PC

Ridgewood, New York, 11385, United States

Location

Albert Einstein's College of Medicine

The Bronx, New York, 10461-1900, United States

Location

Kidney Medical Associates, PLLC

The Bronx, New York, 10461-2710, United States

Location

Mountain Kidney & Hypertension Associates (MKHA), P.A - Asheville

Asheville, North Carolina, 28801-4104, United States

Location

Physicians East, PA

Greenville, North Carolina, 27834, United States

Location

Eastern Nephrology Associates - Jacksonville

Jacksonville, North Carolina, 28546, United States

Location

Eastern Nephrology Associates - New Bern

New Bern, North Carolina, 28562-5200, United States

Location

North Carolina Nephrology P.A.

Raleigh, North Carolina, 27609-7511, United States

Location

Brookview Hills Research Associates, LLC

Winston-Salem, North Carolina, 27103-7108, United States

Location

Providence Health Partners-Center for Clinical Research

Dayton, Ohio, 45439, United States

Location

Columbia Nephrology Associates, PA

Columbia, South Carolina, 29203-6476, United States

Location

Knoxville Kidney Center, PLLC

Knoxville, Tennessee, 37923-3624, United States

Location

Gamma Clinical Research Institute

Austin, Texas, 78503, United States

Location

Davita Clinical Research El Paso

El Paso, Texas, 79925, United States

Location

Kidney Consultants of El Paso, P.A.

El Paso, Texas, 79935, United States

Location

DaVita Clinical Research Houston

Houston, Texas, 77004, United States

Location

Pioneer Research Solutions, Inc.

Houston, Texas, 77099, United States

Location

Clinical Advancement Center, PLLC

San Antonio, Texas, 78212-4738, United States

Location

Urology San Antonio - North Central

San Antonio, Texas, 78229-3342, United States

Location

DaVita Clinical Research

San Antonio, Texas, 78251, United States

Location

Kidney Specialists of North Houston, PLLC

The Woodlands, Texas, 77384, United States

Location

Davita Norfolk Square

Norfolk, Virginia, 23502, United States

Location

Dominion Medical Associates, Inc.

Richmond, Virginia, 23219, United States

Location

Clinical Investigation Specialists

Kenosha, Wisconsin, 53142, United States

Location

Milwaukee Nephrologists, SC (Rich)

Wauwatosa, Wisconsin, 53226, United States

Location

Renal Research

Gosford, New South Wales, 2250, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Clinical Center University of Sarajevo

Sarajevo, Kanton Sarajevo, 71000, Bosnia and Herzegovina

Location

Univerzitetski klinicki centar Republike Srpske - Internal Medicine, Nephrology

Banja Luka, Republika Srpska, 78000, Bosnia and Herzegovina

Location

The University Hospital Foca

Foča, Republika Srpska, 73300, Bosnia and Herzegovina

Location

General Hospital Gradiska

Gradiška, Republika Srpska, 78400, Bosnia and Herzegovina

Location

General hospital Trebinje - Gastroenterology

Trebinje, Republika Srpska, 89101, Bosnia and Herzegovina

Location

General Hospital Tesanj

Tešanj, Zeničko-dobojski Kanton, 72460, Bosnia and Herzegovina

Location

5 th MHAT

Sofia, Sofia-Grad, 1233, Bulgaria

Location

Medical Center Excelsior

Sofia, Sofia-Grad, 1407, Bulgaria

Location

UMHAT St. Ekaterina

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Comac Medical Ltd

Sofia, Sofia-Grad, 1612, Bulgaria

Location

Mhat Dr.Tota Venkova

Gabrovo, 5300, Bulgaria

Location

Medical Center Hera EOOD

Montana, 3400, Bulgaria

Location

UMHAT Kaspela

Plovdiv, 4002, Bulgaria

Location

Medical Center "Teodora"

Rousse, 7012, Bulgaria

Location

DCC 22 - Sofia

Sofia, 1113, Bulgaria

Location

Medical Center Hera EOOD

Sofia, 1510, Bulgaria

Location

Medical Center ''Synexus Sofia'' EOOD

Sofia, 1784, Bulgaria

Location

University Hospital of Active Treatment Prof. Stoyan Kirkovich

Stara Zagora, 6000, Bulgaria

Location

MHAT"Sv.Anna-Varna"AD

Varna, 9002, Bulgaria

Location

Dr. Stephen S. Chow Medicine Professional Corporation

Toronto, Ontario, M4C 5T2, Canada

Location

Clinical Research Solutions Incorporated

Waterloo, Ontario, N2T 0C1, Canada

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing An Zhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Zhongshan Hospital Xiamen University

Xiamen, Fujian, 361004, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

Guangzhou First People's Hospital - Nephrology

Guangzhou, Guangdong, 510180, China

Location

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

The People's Hospital of Guangxi Zhuang Autonomous Region- Nephrology

Nanning, Guangxi, 530021, China

Location

The Affliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 50004, China

Location

The First Affiliated Hospital of Zhengzhou University (East Compus)

Zhengzhou, Henan, China

Location

The Central Hospital of Wuhan

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Wuxi People's Hospital

Wuxi, Jiangsu, 214023, China

Location

The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Nei Mongol (mn), 014010, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Shandong Provincial Hospital

Jinan, Shandong, China

Location

Yantai Yuhuangding Hospital(Base Cpmpus)

Yantai, Shandong, 264000, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Sichuan Academy of Medical Sciences

Chengdu, Sichuan, 610072, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Zhejiang Hospital

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Jinhua Central Hospital

Jinhua, Zhejiang, 321000, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

The Southwest Hospital of AMU

Chongqing, 400038, China

Location

Shanghai Sixth People's Hospital

Shanghai, 200233, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

University Hospital Centre Zagreb

Zagreb, City of Zagreb, 10000, Croatia

Location

Opca bolnica Vinkovci

Vinkovci, Osjecko-baranjska Županija, 32100, Croatia

Location

University Hospital Center Split

Split, 21000, Croatia

Location

Nefrologie s.r.o.

Prague, Praha 4, 149 00, Czechia

Location

Nemocnice Trebic, p.o.

Třebíč, Třebíč, 674 01, Czechia

Location

IKEM

Prague, 140 21, Czechia

Location

Alaron s.r.o.

Prague, 160 00, Czechia

Location

LTD "High technology hospital MEDCENTER"

Batumi, Adjara, 6000, Georgia

Location

Ltd Marnecor

Marneuli, Kvemo Kartli, 3000, Georgia

Location

Ministry of Defence of Georgia LEPL Giorgi Abramishvili Military Hospital

Gori, Shida Kartli, 1400, Georgia

Location

JSC "Evex Hospitals'

Batumi, 6010, Georgia

Location

Aleksandre Aladashvili Clinic LLC

Tbilisi, 0102, Georgia

Location

LTD Israel-Georgian Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

"Pineo Medical Ecosystem"LTD

Tbilisi, 0114, Georgia

Location

JSC German Clinic

Tbilisi, 0119, Georgia

Location

National Center of Urology Named after Laur Managadze

Tbilisi, 0144, Georgia

Location

Bokhua Memorial Cardiovascular Centre

Tbilisi, 0159, Georgia

Location

Emergency Cardiology Center named by acad. G. Chapidze

Tbilisi, 0159, Georgia

Location

J.S.C."K.Eristavi National Center of Experimental and Clinical Surgery"

Tbilisi, 0159, Georgia

Location

Nephrologisches Zentrum Villingen-Schwenningen

Villingen-Schwenningen, Baden-Wurttemberg, 78052, Germany

Location

Diabeteszentrum DO

Dortmund, North Rhine-Westphalia, 44137, Germany

Location

DaVita Clinical Research Germany GmbH

Düsseldorf, North Rhine-Westphalia, 23538, Germany

Location

Universitätsklinikum Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Charité- Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Jena

Jena, 07747, Germany

Location

Queen Mary Hospital - Medicine

Hong Kong, Hong Kong

Location

Tung Wah Hospital

Hong Kong, Hong Kong

Location

Coromed-Smo Kft.

Pécs, Baranya, 7624, Hungary

Location

IPR Hungary Kft.

Miskolc, Borsod-Abauj Zemplen county, 3530, Hungary

Location

Sonocor Egészségügyi Szolgáltató Kft.

Szeged, Csongrád megye, 6725, Hungary

Location

TaNa Med Kft

Mosonmagyaróvár, Győr-Moson-Sopron, 7624, Hungary

Location

BKS Research

Hatvan, Heves County, H-3000, Hungary

Location

Kistarcsai Flor Ferenc Korhaz

Kistarcsa Hungary, Pest County, 2143, Hungary

Location

DRC Gyógyszervizsgáló Központ Kft.

Balatonfüred, Veszprém City, 8230, Hungary

Location

Semmelweis Egyetem

Budapest, 1083, Hungary

Location

Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet

Budapest, 1204, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, H-7400, Hungary

Location

Rabin Medical Center

Petah Tikwa, Central District, 49100, Israel

Location

Nazareth Hospital EMMS

Nazareth, Northern District, 16100, Israel

Location

Dace Teterovska - Doctor's Practice

Ogre, Ogre, Latvia

Location

P.Stradina Clinical University Hospital

Riga, Latvia

Location

Saules seimos medicinos centras

Kaunas, Kaunas County, LT-49449, Lithuania

Location

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, 15586, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

Location

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Hospital Raja Permaisuri Bainun

Ipoh, Perak, 30450, Malaysia

Location

Hospital Seri Manjung

Seri Manjung, Perak, 32400, Malaysia

Location

NZOZ Euromedica Sp. z o.o.

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

Location

Prywatny Gabinet Lekarski i Wizyty Lekarskie Jan Ruxer

Lodz, Lódzkie, 94-074, Poland

Location

Synexus Polska Sp. z o.o.

Katowice, 40-040, Poland

Location

Synexus Polska Sp. z. o.o.

Lodz, 90127, Poland

Location

SP ZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, 92-213, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

Lublin, 20954, Poland

Location

Synexus Polska Sp. z o.o.

Poznan, 60-702, Poland

Location

Synexus Polska Sp. z o.o.

Warsaw, 02-672, Poland

Location

WroMedica I. Bielicka, A. Strzalkowska s.c.

Wroclaw, 51-685, Poland

Location

Clinical Hospital Centre Zemun

Zemun, Belgrade, 11080, Serbia

Location

Clinical Centre Nis

Niš, Nišavski Okrug, 18000, Serbia

Location

Clinical Center Vojvodina

Novi Sad, Vojvodina, 21000, Serbia

Location

Military Medical Academy

Belgrade, 11000, Serbia

Location

Zvezdara University Medical Center

Belgrade, 11000, Serbia

Location

MSB General hospital - Clinical Research Center

Belgrade, Serbia

Location

Clinical Center Kragujevac

Kragujevac, 33126-3422, Serbia

Location

Iatros International

Bloemfontein, Free State, 9301, South Africa

Location

Charlotte Maxeke Johannesburg Hospital

Soweto, Gauteng, 2193, South Africa

Location

Office of Gulam Hoosain Vally

Durban, KwaZulu-Natal, 4001, South Africa

Location

Tiervlei Trial Centre

Bellville, Cape Town, Western Cape, 7530, South Africa

Location

Dr J.M. Engelbrecht Trial Site

Somerset West, Western Cape, 7130, South Africa

Location

Chungnam National University Hospital - Nephrology

Daejeon, Daejeon Gwang'yeogsi [Taejon-Kwangyokshi], 35015, South Korea

Location

National Health Insurance Service Ilsan Hospital - Nephrology

Goyang-si, Gyeonggido [Kyonggi-do], 10444, South Korea

Location

Seoul National University Hospital - Nephrology

Jongno-gu, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03080, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System - Internal Medicine

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6273, South Korea

Location

Samsung Medical Center - Nephrology

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6351, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 6591, South Korea

Location

Hospital público da Mariña

Burela de Cabo, Lugo, 27880, Spain

Location

Hospital Ribera Polusa

Burela de Cabo, Lugo, 27880, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, Valenciana, Comunidad, 46014, Spain

Location

FUNDACION PUIGVERT - Nephrology Department

Barcelona, 08025, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

Hospital Quironsalud Barcelona

Barcelona, 8023, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 8035, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario Y Politécnico La Fe

Valencia, 46026, Spain

Location

Taichung Veterans General Hospital - Nephrology

Taichung, Taichung Municipality, 40705, Taiwan

Location

National Taiwan University Hospital - Nephrology

Taipei, Taipei Special Muncipality, 10002, Taiwan

Location

China Medical University Hospital - Nephrology - Taichung

Taichung, 406, Taiwan

Location

Taipei Medical University - Shuang Ho Hospital - Nephrology

Taipei, 110, Taiwan

Location

Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Nephrology

Taoyuan District, 33305, Taiwan

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Interventions

KBP-5074

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All individuals directly involved in the conduct of the study, including participants, Investigators, site staff, clinical research organization (CRO) personnel, and Sponsor study personnel, will remain blinded to treatment assignments until all participants have completed the Week 56 end of study (EOS) Visit (Visit 17) and the database locked in preparation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 20, 2021
• Study Start: November 5, 2021
• Primary Completion: January 30, 2024
• Study Completion: July 10, 2024
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (5); CR (3); CN (35); TW (5); PL (9); KR (6); DE (8); SE (7); ZA (5); BO (6); CZ (4); CA (2); HK (2); ES (10); BU (13); HU (10); LA (2); GE (12); LI (1); US (65); AU (3); IL (2)