| Outcome Measures: |
Primary: 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: Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16, UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units 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 \[Day 5, 6 of specified Week\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of specified Week\]) 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 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, UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR 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 \[Day 5, 6 of Week 3, 6, 12, 16\], and with last sample collected on the morning of scheduled clinic visit \[Day 7 of Week 3, 6, 12, 16\]) were used to determine UPCR 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 UPCR., 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, The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) = 175\*(sCr/88.4)\^-1.154\*(Age)\^-0.203\*(0.742 if female)\*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1)., Baseline, Week 3, 6, 12, 16 (follow-up)|Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16, Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + (\[systolic blood pressure - diastolic blood pressure\]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart., Week 0, 3, 6, 12, 16 (follow-up)|Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16, Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1)., Baseline, Week 3, 6, 12, 16 (follow-up)|Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16, TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1)., Baseline, Week 3, 6, 12, 16 (follow-up)|Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16, The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1)., Baseline, Week 12, 16 (follow-up)|Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16, Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1)., Baseline, Week 12, 16 (follow-up)|Plasma Concentration Versus Time Summary of PF-00489791, Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6 | Other: Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16, Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1)., Baseline, Week 12, 16 (follow-up)|Number of Participants With Vital Signs Abnormalities, Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than \[\<\] 90 mmHg and increase or decrease of greater than or equal to \[\>=\] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (\<50 mmHg and increase or decrease of \>=20 mmHg compared to baseline value), supine pulse rate (\>120 beats per minute \[bpm\] or \<40 bpm), standing pulse rate (\>140 bpm or \<40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported., Baseline up to Week 16 (follow-up)|Number of Participants With Edema and Fluid Overload, Participants were assessed for signs of edema and fluid overload., Week 0, 3, 6, 12, 16 (follow-up)|Number of Participants With Increased Use of Diuretics, Baseline up to Week 16 (follow-up)|Number of Participants With Laboratory Test Abnormalities, Criteria for laboratory test abnormalities: Hematology (hemoglobin \[\<0.8\*lower limit of normal{LLN}\], hematocrit \[\<0.8\*LLN\], red blood cells \[\<0.8\*LLN\], platelet \[\<0.5\*LLN/\>1.75\*upper limit of normal{ULN}\], white blood cells \[\<0.6\*LLN/\>1.5\*ULN\], lymphocytes \[\<0.8\*LLN/\>1.2\*ULN\], neutrophils \[\<0.8\*LLN/\>1.2\*ULN\], basophils \[\>1.2\*ULN\], eosinophils \[\>1.2\*ULN\], monocytes \[\>1.2\*ULN\]); Liver Function (total/direct/indirect bilirubin \[\>1.5\*ULN\], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase \[\>3.0\*ULN\]); Renal Function (blood urea nitrogen/ creatinine \[\>1.3\*ULN\], uric acid \[\>1.2\*ULN\]); Electrolytes (sodium \[\<0.95\*LLN/\>1.05\*ULN\], potassium, chloride, calcium, bicarbonate \[\<0.9\*LLN/\>1.1\*ULN\]); Clinical Chemistry (glucose \[\<0.6\*LLN/\>1.5\*ULN\], glycosylated hemoglobin \[\>1.3\*ULN\], Creatine Kinase \[\>2.0\*ULN\], Amylase, Lipase\[\>1.5\*ULN\])., Baseline up to Week 16 (follow-up)|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs), Baseline up to Week 16 (follow-up)
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| Locations: |
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, 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, 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, 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|Pharmacy, Seongnam-si, Gyeonggi-do, 463-707, Korea, Republic of|Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, 463-707, Korea, Republic of|Clinical Trial Pharmacy, Seongnam-si, 463-707, Korea, Republic of|Seoul National University Hospital, Seoul, 110-744, Korea, Republic of|Samsung Medical Center, Department of Pharmacy, Seoul, 135-710, Korea, Republic of|Samsung Medical Center,Sungkyunkwan Univ School of Medicine, Seoul, 135-710, Korea, Republic of|Samsung Medical Center/Division of Nephrology, Seoul, 135-710, Korea, Republic of|Boramae Medical Center/Division of Nephrology, Seoul, 156-707, Korea, Republic of|SMG-SNU Boramae Medical Center, Seoul, 156-707, Korea, Republic of|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|Comite Mexicano para la Prevencion de la Osteoporosis, A.C., Mexico, DF, 06100, Mexico|ICLE SC, Guadalajara, Jalisco, 44600, 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 Potosi, San Luis, 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|Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw, 4749, Poland|Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow, Warszawa, 02-256, Poland|Centrum Medyczne "OSTEOMED" NZOZ, Warszawa, 02-256, Poland|Centrum Medyczne "Osteomed", Warszawa, 02-256, Poland|Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw, Warszawa, 02-256, 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, Nis, 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, Presov, 081 81, Slovakia|Vseobecna nemocnica Rimavska Sobota, Rimavska Sobota, 979 12, Slovakia|Wits Clinical research, Johannesburg, Gauteng- South Africa, 2096, South Africa|Worthwhile Clinical Trials (WWCT), Lake View Hospital, Benoni, Gauteng, 1500, South Africa|Dr. George Mukhari Hospital -University of Limpopo, Pretoria, Gauteng, 0204, 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|Sahlgrenska University Hospital Njurmottagningen, Goteborg, 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
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