This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200394
First received: September 10, 2010
Last updated: August 9, 2017
Last verified: August 2017
  Purpose
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.

Condition Intervention Phase
Diabetic Nephropathies Drug: PF-00489791 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Urine albumin: creatinine ratio (UACR) [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Urine albumin: creatinine ratio at 3, 6 and 16 weeks [ Time Frame: 16 weeks ]
  • Urine protein: creatinine ratio at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  • Estimated glomerular filtration rate at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  • Systolic, diastolic and mean arterial blood pressure at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  • Serum creatinine at 3, 6, 12 and 16 weeks [ Time Frame: 16 weeks ]
  • Urinary TGFbeta1 at Weeks 3, 6, 12 and 16. [ Time Frame: 16 weeks ]
  • Serum C-reactive protein (hs-CRP) at Weeks 12 and 16. [ Time Frame: 16 weeks ]
  • Serum cystatin C at Weeks 12 and 16. [ Time Frame: 16 weeks ]
  • An assessment of the pharmacokinetic parameters of PF-00489791. [ Time Frame: 16 weeks ]
  • Plasma glycosylated hemoglobin (HbA1c). [ Time Frame: 16 weeks ]
  • Safety and tolerability measures (AEs, clinical laboratory assessments, physical examination including weight, worsening of edema, increased use of diuretics). [ Time Frame: 16 weeks ]

Enrollment: 256
Actual Study Start Date: December 2010
Study Completion Date: August 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-00489791 Drug: PF-00489791
Tablet, 20 mg once daily for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Tablet, placebo once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394

  Hide Study Locations
Locations
United States, Alabama
Saadat Ansari Internal Medicine
Huntsville, Alabama, United States, 35801
The Office of Iqbal Saeed MD, LLC
Huntsville, Alabama, United States, 35805
United States, Arizona
AKDHC Medical Research Services, LLC*
Glendale, Arizona, United States, 85306
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States, 85281
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States, 85284
United States, California
North America Research Institute
Azusa, California, United States, 91702
North American Research Institute / California Kidney Specialist
Azusa, California, United States, 91702
Citrus Dialysis Center
Covina, California, United States, 91723
California Institute of Renal Research
La Mesa, California, United States, 91942
Capital Nephrology Clinical Research
Sacramento, California, United States, 95825
California Kidney Specialists
San Dimas, California, United States, 91773
American Institute of Research
Whittier, California, United States, 90602
Whittier Internal Medicine Nephrology Medical Group
Whittier, California, United States, 90602
North Valley Nephrology
Yuba, California, United States, 95991
United States, Florida
Riverside Clinical Research
Edgewater, Florida, United States, 32132
Palm Springs Research Institute
Hialeah, Florida, United States, 33012
ASA Clinical Research, LLC
Jupiter, Florida, United States, 33458
Lakeview Medical Research
Summerfield, Florida, United States, 34491
United States, Georgia
Rockdale Medical Research Associates
Conyers, Georgia, United States, 30094
Renal Physicians of Georgia
Macon, Georgia, United States, 31217
United States, Idaho
Boise Kidney and Hypertension Institute
Meridian, Idaho, United States, 83642
United States, Illinois
Chicago Clinical Research Institute, Inc.
Chicago, Illinois, United States, 60616
Associates in Nephrology, SC
Evergreen Park, Illinois, United States, 60805
Research by Design, LLC
Evergreen Park, Illinois, United States, 60805
RenalCare Associates
Peoria, Illinois, United States, 61603
United States, Indiana
Investigative Clinical Research of Indiana, LLC
Elwood, Indiana, United States, 46036
United States, Kansas
Kansas Nephrology Research Institute, LLC
Wichita, Kansas, United States, 67214
United States, Kentucky
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States, 42003
United States, Louisiana
Crescent City Clinical Research Center
Metairie, Louisiana, United States, 70006
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States, 71101
United States, Maryland
Biolab Research, LLC
Rockville, Maryland, United States, 20852
United States, Michigan
Alzohaili Medical Consultants
Dearborn, Michigan, United States, 48124
Apex Medical Research, AMR, Inc.
Flint, Michigan, United States, 48504
Apex Medical Research, MI, Inc.
Flint, Michigan, United States, 48504
United States, Missouri
Clinical Research Consultants, LLC
Kansas City, Missouri, United States, 64111
United States, Nebraska
Lincoln Nephrology and Hypertension
Lincoln, Nebraska, United States, 68510
Nebraska Nephrology Research Institute, LLC - Research Management, Inc.
Lincoln, Nebraska, United States, 68510
United States, Nevada
Alliance Against Diabetes
Las Vegas, Nevada, United States, 89101
Clinical Research Consortium
Las Vegas, Nevada, United States, 89119
United States, New York
Jacobi Medical Center - Department of Medicine - Nephrology
The Bronx, New York, United States, 10461
United States, North Carolina
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, United States, 28801
Trial Management Associates
Wilmington, North Carolina, United States, 28401
United States, Ohio
Lake Medical Research
Willoughby Hills, Ohio, United States, 44094
United States, Pennsylvania
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States, 18017
Preferred Primary Care Physicians, Inc.
Uniontown, Pennsylvania, United States, 15401
United States, South Carolina
Columbia Nephrology Associates, PA
Columbia, South Carolina, United States, 29203
Carolina Nephrology, PA
Greenville, South Carolina, United States, 29605
Palmetto Nephrology, PA
Orangeburg, South Carolina, United States, 29118
South Carolina Nephrology & Hypertension Ctr, Inc
Orangeburg, South Carolina, United States, 29118
South Carolina Nephrology and Hypertension Center
Orangeburg, South Carolina, United States, 29118
United States, Texas
Central Texas Kidney Associates
Austin, Texas, United States, 78751
Research Management, Inc.
Austin, Texas, United States, 78751
Diagnostic Clinic of Houston, PA
Houston, Texas, United States, 77004
Houston Nephrology Research
Houston, Texas, United States, 77024
Research Across America
Houston, Texas, United States, 77054
Renal Associates, PA
San Antonio, Texas, United States, 78215
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, United States, 78229
United States, Virginia
Nephrology Associates of Northern Virginia, Inc.
Fairfax, Virginia, United States, 22033
Nephrology Specialists, P.C.
Mechanicsville, Virginia, United States, 23116
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Washington
Renal Remission & Hypertension Consultants, PLLC
Bremerton, Washington, United States, 98310
Sound Medical Research
Port Orchard, Washington, United States, 98366
Renal Remission and Hypertension Clinic
Silverdale, Washington, United States, 98383
Australia, New South Wales
Renal Research Practice
Gosford, New South Wales, Australia, 2250
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
Australia, Newcastle
Department of Nephrology
New Lambton, Newcastle, Australia, 2305
Pharmacy Department
New Lambton, Newcastle, Australia, 2305
Australia, Victoria
Melbourne Renal Research Group
Reservoir, Victoria, Australia, 3073
Canada, Alberta
Sheldon M Chumir Health Centre
Calgary, Alberta, Canada, T2N 0X7
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Entralogix Clincal Research Inc.
Brampton, Ontario, Canada, L6Z 4N5
Entralogix Clinical Research Inc.
Brampton, Ontario, Canada, L6Z 4N5
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Entralogix Clinical Research Inc.
Oakville, Ontario, Canada, L6J 3M5
N/A - formerly with Entralogix SMO
Toronto, Ontario, Canada, M4C 5T2
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre de sante et de services sociaux champlain-Charles-Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
Centre de Dialyse de Bois de Boulogne
Montreal, Quebec, Canada, H3M 3E3
Hopital de Sacre Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Canada, Saskatchewan
Saskatoon Nephrology Group, Nurses Redisence
Saskatoon, Saskatchewan, Canada, S7M 2Z1
Saskatoon Nephrology Group, Nurses Residence
Saskatoon, Saskatchewan, Canada, S7M 2Z1
Saskatoon Nephrology Group
Saskatoon, Saskatchewan, Canada, S7M 2Z1
Denmark
Aarhus Universitetshospital (Aarhus Sygehus)
Aarhus, Denmark, 8000
Rigshospitalet
Copenhagen Oe, Denmark, 2100
Steno Diabetes Center
Gentofte, Denmark, 2820
Hong Kong
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, Hong Kong, N.T. 0
India
Apollo Hospitals
Hyderabad, Andhra Pradesh, India, 500096
Gujarat Kidney Foundation
Ahmedabad, Gujarat, India, 380 007
Shrushrut Clinical Research Association
Ahmedabad, Gujarat, India, 380 013
P. D. Hinduja National Hospital and Medical Research Centre
Mumbai, Maharashtra, India, 400016
Pfizer Centre
Mumbai, Maharashtra, India, 400102
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India, 411 004
Diabetes Care and Research Centre
Pune, Maharashtra, India, 411 011
KE.M Hospital Research Centre
Pune, Maharashtra, India, 411 011
King Edward Memorial Hospital
Pune, Maharashtra, India, 411 011
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, India, 411001
Korea, Republic of
Pharmacy
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Clinical Trial Pharmacy
Seongnam-si, Korea, Republic of, 463-707
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center, Department of Pharmacy
Seoul, Korea, Republic of, 135-710
Samsung Medical Center,Sungkyunkwan Univ School of Medicine
Seoul, Korea, Republic of, 135-710
Samsung Medical Center/Division of Nephrology
Seoul, Korea, Republic of, 135-710
Boramae Medical Center/Division of Nephrology
Seoul, Korea, Republic of, 156-707
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Malaysia
Universiti Sains Malaysia
Kota Bharu, Kelantan, Malaysia, 16150
Unit Kajian Klinikal, Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150,
Hospital Taiping
Taiping, Perak, Malaysia, 34000
Clinical Research Centre, Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia, 10990
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia, 10990
Nephrology Clinic, Queen Elizabeth Hospital
Kota Kinabalu, Sabah, Malaysia, 88586
Unit Hemodialisis, Hospital Serdang
Kajang, Selangor, Malaysia, 43000
Mexico
Comite Mexicano para la Prevencion de la Osteoporosis, A.C.
Mexico, DF, Mexico, 06100
ICLE SC
Guadalajara, Jalisco, Mexico, 44600
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
Tlalpan, Mexico City, Mexico, 14000
Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Osteoporosis
San Luis Potosi, San Luis, Mexico, 78240
Hospital Angeles del Pedregal
Angeles del Pedregal Cp., Mexico, 10700
Poland
NZOZ "DIAGNOMED" S.C., Poradnia Nefrologiczna
Bielsko-Biala, Poland, 43-300
Samodzielny Publiczny Szpital Kliniczny im Andrzeja Mieleckiego
Katowice, Poland, 40-027
NZOZ PS "Medica"
Lublin, Poland, 20-538
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, Poland, 4749
Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow
Warszawa, Poland, 02-256
Centrum Medyczne "OSTEOMED" NZOZ
Warszawa, Poland, 02-256
Centrum Medyczne "Osteomed"
Warszawa, Poland, 02-256
Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw
Warszawa, Poland, 02-256
SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
Wroclaw, Poland, 50-556
Serbia
Clinical Center of Serbia Institute for Endocrinology, Diabetes and Metabolic Diseases
Belgrade, Serbia, 11 000
Clinic for Nephrology, Military Medical Academy
Belgrade, Serbia, 11000
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Hospital Center "Zvezdara"
Belgrade, Serbia, 11000
Clinical Hospital Center Zvezdara
Belgrade, Serbia, 11000
Clinic for Endocrinology, Clinical Center Nis
Nis, Serbia, 18000
Slovakia
FNsP Bratislava, Nemocnica Stare Mesto
Bratislava, Slovakia, 813 69
Nemocnice s poliklinikami n.o.
Levice, Slovakia, 934 01
Fakultna nemocnica s poliklinikou J.A.Reimana Presov
Presov, Slovakia, 081 81
Vseobecna nemocnica Rimavska Sobota
Rimavska Sobota, Slovakia, 979 12
South Africa
Wits Clinical research
Johannesburg, Gauteng- South Africa, South Africa, 2096
Worthwhile Clinical Trials (WWCT), Lake View Hospital
Benoni, Gauteng, South Africa, 1500
Dr. George Mukhari Hospital -University of Limpopo
Pretoria, Gauteng, South Africa, 0204
Centre for Diabetes and Endocrinology
Durban, Kwazulu Natal, South Africa, 4091
Latros International
Bloemfontein, South Africa, 9301
Division of Nephrology and Hypertension, E13 Renal Unit
Cape Town, South Africa, 7925
St Augustine's Hospital
Durban, South Africa, 4001
Centre for Diabetes and Endocrinology
Durban, South Africa, 4091
Centre for Diabetes and Endocrinology
Houghton, Johannesburg, South Africa, 2198
Intercare Parow Medical and Dental Centre
Parow, South Africa, 7500
Medi-Clinic Heart Hospital (Pretoria Heart Hospital)
Pretoria, South Africa, 132
Sweden
Sahlgrenska University Hospital Njurmottagningen
Goteborg, Sweden, 413 45
A+ Science City site
Stockholm, Sweden, 111 57
Akademiska Sjukhuset
Uppsala, Sweden, 751 85
United Kingdom
Doncaster Royal Infirmary
Doncaster, South Yorkshire, United Kingdom, DN2 5LT
Research Offices (5th Floor)
Coventry, United Kingdom, CV2 2DX
University of Edinburgh
Edinburgh, United Kingdom, EH16 4TJ
The Royal London Hospital Whitechapel
London, United Kingdom, E1 1BB
Guy's and St Thomas' Foundation Trust
London, United Kingdom, SE1 9RT
Northern General Hospital Campus
Sheffield, United Kingdom, S5 7AU
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01200394     History of Changes
Other Study ID Numbers: A7331011
2010-021358-20 ( EudraCT Number )
Study First Received: September 10, 2010
Last Updated: August 9, 2017

Keywords provided by Pfizer:
Diabetic nephropathy
chronic kidney disease
PF-00489791
phosphodiesterase
PDE5

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 17, 2017