A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY
2 other identifiers
interventional
256
14 countries
154
Brief Summary
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
154 active sites
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
September 10, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
March 12, 2019
CompletedMarch 12, 2019
February 1, 2019
2.6 years
September 10, 2010
January 3, 2019
February 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to \[Day 5, 6 of Week 12\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of Week 12\]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
Baseline, Week 12 (Day 5, 6, 7)
Secondary Outcomes (9)
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Baseline, Week 3, 6, 12, 16 (follow-up)
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Week 0, 3, 6, 12, 16 (follow-up)
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Baseline, Week 3, 6, 12, 16 (follow-up)
- +4 more secondary outcomes
Other Outcomes (6)
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16
Baseline, Week 12, 16 (follow-up)
Number of Participants With Vital Signs Abnormalities
Baseline up to Week 16 (follow-up)
Number of Participants With Edema and Fluid Overload
Week 0, 3, 6, 12, 16 (follow-up)
- +3 more other outcomes
Study Arms (2)
PF-00489791
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
- Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
- Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.
You may not qualify if:
- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- Subjects with poorly controlled diabetes mellitus, defined as HbA1C \>9%.
- Subjects on combination ACE inhibitor/ARB therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (160)
Saadat Ansari Internal Medicine
Huntsville, Alabama, 35801, United States
The Office of Iqbal Saeed MD, LLC
Huntsville, Alabama, 35805, United States
AKDHC Medical Research Services, LLC*
Glendale, Arizona, 85306, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, 85281, United States
Southwest Clinical Research Institute, LLC
Tempe, Arizona, 85284, United States
North America Research Institute
Azusa, California, 91702, United States
North American Research Institute / California Kidney Specialist
Azusa, California, 91702, United States
Citrus Dialysis Center
Covina, California, 91723, United States
California Institute of Renal Research
La Mesa, California, 91942, United States
Capital Nephrology Clinical Research
Sacramento, California, 95825, United States
California Kidney Specialists
San Dimas, California, 91773, United States
American Institute of Research
Whittier, California, 90602, United States
Whittier Internal Medicine Nephrology Medical Group
Whittier, California, 90602, United States
North Valley Nephrology
Yuba City, California, 95991, United States
Riverside Clinical Research
Edgewater, Florida, 32132, United States
Palm Springs Research Institute
Hialeah, Florida, 33012, United States
ASA Clinical Research, LLC
Jupiter, Florida, 33458, United States
Lakeview Medical Research
Summerfield, Florida, 34491, United States
Rockdale Medical Research Associates
Conyers, Georgia, 30094, United States
Renal Physicians of Georgia
Macon, Georgia, 31217, United States
Boise Kidney and Hypertension Institute
Meridian, Idaho, 83642, United States
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, 60616, United States
Associates in Nephrology, SC
Evergreen Park, Illinois, 60805, United States
Research by Design, LLC
Evergreen Park, Illinois, 60805, United States
RenalCare Associates
Peoria, Illinois, 61603, United States
Investigative Clinical Research of Indiana, LLC
Elwood, Indiana, 46036, United States
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, 67214, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003, United States
Crescent City Clinical Research Center
Metairie, Louisiana, 70006, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
Biolab Research, LLC
Rockville, Maryland, 20852, United States
Alzohaili Medical Consultants
Dearborn, Michigan, 48124, United States
Apex Medical Research, AMR, Inc.
Flint, Michigan, 48504, United States
Apex Medical Research, MI, Inc.
Flint, Michigan, 48504, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
Lincoln Nephrology and Hypertension
Lincoln, Nebraska, 68510, United States
Nebraska Nephrology Research Institute, LLC - Research Management, Inc.
Lincoln, Nebraska, 68510, United States
Alliance Against Diabetes
Las Vegas, Nevada, 89101, United States
Clinical Research Consortium
Las Vegas, Nevada, 89119, United States
Jacobi Medical Center - Department of Medicine - Nephrology
The Bronx, New York, 10461, United States
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, 28801, United States
Trial Management Associates
Wilmington, North Carolina, 28401, United States
Lake Medical Research
Willoughby Hills, Ohio, 44094, United States
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, 18017, United States
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, 15401, United States
Columbia Nephrology Associates, PA
Columbia, South Carolina, 29203, United States
Carolina Nephrology, PA
Greenville, South Carolina, 29605, United States
Palmetto Nephrology, PA
Orangeburg, South Carolina, 29118, United States
South Carolina Nephrology & Hypertension Ctr, Inc
Orangeburg, South Carolina, 29118, United States
South Carolina Nephrology and Hypertension Center
Orangeburg, South Carolina, 29118, United States
Central Texas Kidney Associates
Austin, Texas, 78751, United States
Research Management, Inc.
Austin, Texas, 78751, United States
Diagnostic Clinic of Houston, PA
Houston, Texas, 77004, United States
Houston Nephrology Research
Houston, Texas, 77024, United States
Research Across America
Houston, Texas, 77054, United States
Renal Associates, PA
San Antonio, Texas, 78215, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, 78229, United States
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, 22033, United States
Nephrology Specialists, P.C.
Mechanicsville, Virginia, 23116, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, 23507, United States
Renal Remission & Hypertension Consultants, PLLC
Bremerton, Washington, 98310, United States
Sound Medical Research
Port Orchard, Washington, 98366, United States
Renal Remission and Hypertension Clinic
Silverdale, Washington, 98383, United States
Renal Research Practice
Gosford, New South Wales, 2250, Australia
John Hunter Hospital
Newcastle, New South Wales, 2305, Australia
Department of Nephrology
New Lambton, Newcastle, 2305, Australia
Pharmacy Department
New Lambton, Newcastle, 2305, Australia
Melbourne Renal Research Group
Reservoir, Victoria, 3073, Australia
Sheldon M Chumir Health Centre
Calgary, Alberta, T2N 0X7, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Entralogix Clincal Research Inc.
Brampton, Ontario, L6Z 4N5, Canada
Entralogix Clinical Research Inc.
Brampton, Ontario, L6Z 4N5, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Entralogix Clinical Research Inc.
Oakville, Ontario, L6J 3M5, Canada
N/A - formerly with Entralogix SMO
Toronto, Ontario, M4C 5T2, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Centre de sante et de services sociaux champlain-Charles-Le Moyne
Greenfield Park, Quebec, J4V 2H1, Canada
Centre de Dialyse de Bois de Boulogne
Montreal, Quebec, H3M 3E3, Canada
Hopital de Sacre Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Saskatoon Nephrology Group, Nurses Redisence
Saskatoon, Saskatchewan, S7M 2Z1, Canada
Saskatoon Nephrology Group, Nurses Residence
Saskatoon, Saskatchewan, S7M 2Z1, Canada
Saskatoon Nephrology Group
Saskatoon, Saskatchewan, S7M 2Z1, Canada
Aarhus Universitetshospital (Aarhus Sygehus)
Aarhus, 8000, Denmark
Rigshospitalet
Copenhagen Oe, 2100, Denmark
Steno Diabetes Center
Gentofte Municipality, 2820, Denmark
Queen Mary Hospital
Hong Kong, Hong Kong
Division of Nephrology, Dept. of Medicine
Pokfulam, Hong Kong
Division of Nephrology
Pokfulam, Hong Kong
ICON Clinical Research
Quarry Bay, Hong Kong
Prince of Wales Hospital
Shatin, N.T. 0, Hong Kong
Apollo Hospitals
Hyderabad, Andhra Pradesh, 500096, India
Gujarat Kidney Foundation
Ahmedabad, Gujarat, 380 007, India
Shrushrut Clinical Research Association
Ahmedabad, Gujarat, 380 013, India
P. D. Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, 400016, India
Pfizer Centre
Mumbai, Maharashtra, 400102, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411 004, India
Diabetes Care and Research Centre
Pune, Maharashtra, 411 011, India
KE.M Hospital Research Centre
Pune, Maharashtra, 411 011, India
King Edward Memorial Hospital
Pune, Maharashtra, 411 011, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, 411001, India
Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150, Malaysia
Unit Kajian Klinikal, Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150,, Malaysia
Hospital Taiping
Taiping, Perak, 34000, Malaysia
Clinical Research Centre, Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Nephrology Clinic, Queen Elizabeth Hospital
Kota Kinabalu, Sabah, 88586, Malaysia
Unit Hemodialisis, Hospital Serdang
Kajang, Selangor, 43000, Malaysia
ICLE SC
Guadalajara, Jalisco, 44600, Mexico
Comite Mexicano para la Prevencion de la Osteoporosis, A.C.
Mexico City, Mexico City, 06100, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
Tlalpan, Mexico City, 14000, Mexico
Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Osteoporosis
San Luis Potosí City, San Luis Potosí, 78240, Mexico
Hospital Angeles del Pedregal
Angeles Del Pedregal Cp., 10700, Mexico
NZOZ "DIAGNOMED" S.C., Poradnia Nefrologiczna
Bielsko-Biala, 43-300, Poland
Samodzielny Publiczny Szpital Kliniczny im Andrzeja Mieleckiego
Katowice, 40-027, Poland
NZOZ PS "Medica"
Lublin, 20-538, Poland
Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow
Warsaw, 02-256, Poland
Centrum Medyczne "OSTEOMED" NZOZ
Warsaw, 02-256, Poland
Centrum Medyczne "Osteomed"
Warsaw, 02-256, Poland
Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw
Warsaw, 02-256, Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, 4749, Poland
SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
Wroclaw, 50-556, Poland
Clinical Center of Serbia Institute for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, 11 000, Serbia
Clinic for Nephrology, Military Medical Academy
Belgrade, 11000, Serbia
Clinical Center of Serbia
Belgrade, 11000, Serbia
Clinical Hospital Center "Zvezdara"
Belgrade, 11000, Serbia
Clinical Hospital Center Zvezdara
Belgrade, 11000, Serbia
Clinic for Endocrinology, Clinical Center Nis
Niš, 18000, Serbia
FNsP Bratislava, Nemocnica Stare Mesto
Bratislava, 813 69, Slovakia
Nemocnice s poliklinikami n.o.
Levice, 934 01, Slovakia
Fakultna nemocnica s poliklinikou J.A.Reimana Presov
Prešov, 081 81, Slovakia
Vseobecna nemocnica Rimavska Sobota
Rimavská Sobota, 979 12, Slovakia
Worthwhile Clinical Trials (WWCT), Lake View Hospital
Benoni, Gauteng, 1500, South Africa
Dr. George Mukhari Hospital -University of Limpopo
Pretoria, Gauteng, 0204, South Africa
Wits Clinical research
Johannesburg, Gauteng- South Africa, 2096, South Africa
Centre for Diabetes and Endocrinology
Durban, KwaZulu-Natal, 4091, South Africa
Latros International
Bloemfontein, 9301, South Africa
Division of Nephrology and Hypertension, E13 Renal Unit
Cape Town, 7925, South Africa
St Augustine's Hospital
Durban, 4001, South Africa
Centre for Diabetes and Endocrinology
Durban, 4091, South Africa
Centre for Diabetes and Endocrinology
Houghton, Johannesburg, 2198, South Africa
Intercare Parow Medical and Dental Centre
Parow, 7500, South Africa
Medi-Clinic Heart Hospital (Pretoria Heart Hospital)
Pretoria, 132, South Africa
Pharmacy
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Clinical Trial Pharmacy
Seongnam-si, 463-707, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Samsung Medical Center, Department of Pharmacy
Seoul, 135-710, South Korea
Samsung Medical Center,Sungkyunkwan Univ School of Medicine
Seoul, 135-710, South Korea
Samsung Medical Center/Division of Nephrology
Seoul, 135-710, South Korea
Boramae Medical Center/Division of Nephrology
Seoul, 156-707, South Korea
SMG-SNU Boramae Medical Center
Seoul, 156-707, South Korea
Sahlgrenska University Hospital Njurmottagningen
Gothenburg, 413 45, Sweden
A+ Science City site
Stockholm, 111 57, Sweden
Akademiska Sjukhuset
Uppsala, 751 85, Sweden
Doncaster Royal Infirmary
Doncaster, South Yorkshire, DN2 5LT, United Kingdom
Research Offices (5th Floor)
Coventry, CV2 2DX, United Kingdom
University of Edinburgh
Edinburgh, EH16 4TJ, United Kingdom
The Royal London Hospital Whitechapel
London, E1 1BB, United Kingdom
Guy's and St Thomas' Foundation Trust
London, SE1 9RT, United Kingdom
Northern General Hospital Campus
Sheffield, S5 7AU, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2010
First Posted
September 13, 2010
Study Start
December 1, 2010
Primary Completion
July 1, 2013
Study Completion
August 1, 2013
Last Updated
March 12, 2019
Results First Posted
March 12, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.