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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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200394
First received: September 10, 2010
Last updated: August 9, 2017
Last verified: August 2017
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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
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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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01200394
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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 September 20, 2017