| Outcome Measures: |
Primary: Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12, The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples., Baseline and Week 12 | Secondary: Change From Baseline in UACR at Weeks 4, 8 and 16, The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples., Baseline, Weeks 4, 8 and 16|Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16, The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples., Baseline, Weeks 4, 8, 12 and 16|Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Using the Abbreviated Modified Diet in Renal Disease (MDRD) Formula at Weeks 1, 4, 8, 12 and 16, eGFR was calculated using the MDRD equation and normalized to 1.73 m\^2 body surface area. Age and corresponding creatinine at each visit (Weeks 1, 4, 8, 12 and 16) were used to calculate GFR, Baseline, Week 1, 4, 8, 12 and 16|Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16, Serum cystatin C may be a more reliable endogenous marker of GFR than serum creatinine. eGFR was calculated using the Cystatin Formula and normalized to 1.73 m\^2 body surface area., Baseline, Week 12, and Week 16|Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16, Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. Normal adult blood levels of creatinine=45 to 90 micromoles per liter (mcmol/L) for females, 60 to 110 mcmol/L for males, however normal values are age-dependent. Change from baseline=creatinine level at Week 1, 4, 8, 12 or 16 minus baseline level where higher scores represented decreased kidney function., Baseline, Week 1, 4, 8, 12 and 16|Change From Baseline in Serum Cystatin C at Weeks 12 and 16, Cystatin C is a protein which is mainly used as a biomarker of kidney function. If kidney function and GFR decline, the blood levels of cystatin C rise., Baseline, Week 12, and Week 16|Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16, HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. As the average amount of plasma glucose increases, the fraction of HbA1c increases in a predictable way., Baseline, Weeks 4, 8, 12 and 16|Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12, 1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12 | Other: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16, Baseline, Weeks 1, 4, 8, 12 and 16|Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16, Baseline, Weeks 1, 4, 8, 12 and 16|Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16, Baseline, Weeks 1, 4, 8, 12 and 16|Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern, The following laboratory parameters were analyzed for abnormalities at any time point mentioned in the timeframe: clinical chemistry (sodium, potassium, chloride, bicarbonate, phosphate, glucose, blood urea nitrogen \[BUN\], creatinine, albumin, calcium, bilirubin \[total, direct, and indirect\], gamma-glutamyl transferase \[GGT\], alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], lactic dehydrogenase \[LDH\], alkaline phosphatase, creatine phosphokinase \[CPK\], uric acid, amylase and lipase); hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, white blood cell \[WBC\] count with differential, and platelet count); FSH (for postmenopausal women who had been amenorrheic for less than 2 years prior to screening)., Baseline up to Week 16 (follow-up visit)|Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings, Criteria for potentially clinically important ECG values were defined as: PR interval \>=300 milliseconds (msec) or \>=25%/50% increase when baseline is \>200 msec and ≥50% increase when baseline is less than or equal to (\<=)200 msec; QRS interval \>=140 msec or \>=50% increase from baseline (IFB); QTc \>=450 msec or \>=30 msec increase; corrected QT interval using Fridericia's formula (QTcF) \>=450 msec or \>=30 msec increase., Baseline, Weeks 1, 4 and 12|Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs), An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was 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 treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-serious AEs., Baseline up to 28 days after last study drug administration|Number of Participants With Increased Fasting Blood Glucose, Baseline up to Week 16 (follow-up visit)
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| Locations: |
Medical Investigations, Inc., Little Rock, Arkansas, 72205, United States|North America Research Institute, Azusa, California, 91702, United States|California Institute of Renal Research, Chula Vista, California, 91910, United States|California Kidney Specialists, Covina, California, 91723, United States|Diabetes/Lipid Management and Research Center, Huntington Beach, California, 92648, United States|Tower Nephrology Medical Group, Los Angeles, California, 90048, United States|Richard S. Cherlin, MD, Los Gatos, California, 95032, United States|Providence Clinical Research, North Hollywood, California, 91606, United States|Desert Oasis Healthcare Medical Group, Palm Springs, California, 92262, United States|Central Coast Nephrology, Salinas, California, 93901, United States|California Kidney Specialists, San Dimas, California, 91773, United States|University of Colorado Denver/University of Colorado Hospital, Aurora, Colorado, 80045, United States|Gulf Coast Endocrine and Diabetes Center, Clearwater, Florida, 33756, United States|Continental Research Corp., Doral, Florida, 33126, United States|Premier Research Associate, Inc., Hialeah, Florida, 33012, United States|Ocean Blue Medical Research Center, Inc, Miami Springs, Florida, 33166, United States|Prestige Clinical Research Center, Miami, Florida, 33133, United States|Elite Clinical Research, Miami, Florida, 33144, United States|Nephrology Associates of South Miami, Miami, Florida, 33173, United States|Tellus Clinical Research, Inc., Miami, Florida, 33173, United States|Diabetes Care Center, New Port Richey, Florida, 34652, United States|Gulf Coast Kidney Center, New Port Richey, Florida, 34652, United States|Suncoast Clinical Research, Inc., New Port Richey, Florida, 34652, United States|Pines Clinical Research, Inc., Pembroke Pines, Florida, 33028, United States|Christie Clinic, LLC, Champaign, Illinois, 61820, United States|Four Rivers Clinical Research, Inc., Paducah, Kentucky, 42003, United States|Crescent City Clinical Research Center, Metairie, Louisiana, 70006, United States|CTRC, Interim LSU Public Hospital, New Orleans, Louisiana, 70112, United States|Pharmacy Department, Interim LSU Public Hospital, New Orleans, Louisiana, 70112, United States|A. Kaldun Nossuli MD Research, Bethesda, Maryland, 20814, United States|Western New England Renal and Transplant Associates, PC, Springfield, Massachusetts, 01107, United States|Hurley Medical Center, Flint, Michigan, 48503, United States|Apex Medical Research, MI, Inc., Flint, Michigan, 48504, United States|Troy Internal Medicine, PC, Troy, Michigan, 48098, United States|Clinical Research Consultants, LLC, Kansas City, Missouri, 64111, United States|VA Medical Center, Kansas City, Missouri, 64128, United States|Creighton Diabetes Center, Omaha, Nebraska, 68131, United States|Renal Medicine Associates, Albuquerque, New Mexico, 87109, United States|Winthrop University Hospital, Division of Nephrology and Hypertension, Mineola, New York, 11501, United States|Winthrop University Hospital, Pharmacy Department, Mineola, New York, 11501, United States|Northport VA Medical Sciences Center, Northport, New York, 11768, United States|Mountain Kidney and Hypertension Associates, PA, Asheville, North Carolina, 28801, United States|East Carolina University Nephrology Research, Greenville, North Carolina, 27834, United States|Down East Medical Associates, P.A., Morehead City, North Carolina, 28557, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Brookview Hills Research Associates, LLC, Winston-Salem, North Carolina, 27103, United States|Rhode Island Hospital, Providence, Rhode Island, 02903, United States|BRAHN-Hypertension and Nephrology, Inc, Providence, Rhode Island, 02904, United States|South Carolina Nephrology and Hypertension Center, Inc., Orangeburg, South Carolina, 29118, United States|The Endocrine Clinic, PC, Memphis, Tennessee, 38119, United States|Nephrology Associates, P.C., Nashville, Tennessee, 37205, United States|Independent Clinical Research, Greenville, Texas, 75402, United States|Clinical Trial Network, Houston, Texas, 77074, United States|Southwest Nephrology Associates, LLP, Houston, Texas, 77074, United States|Southwest Houston Research LTD, Houston, Texas, 77099, United States|Southwest Nephrology Associates, LLP, Richmond, Texas, 77469, United States|Clinical Advancement Center, PLLC, San Antonio, Texas, 78215, United States|Briggs Clinical Research, LLC, San Antonio, Texas, 78224, United States|San Antonio Kidney Disease Center Physicians Group, P.L.L.C., San Antonio, Texas, 78229, United States|Southwest Nephrology Associates, LLP, Sugar Land, Texas, 77478, United States|Southern Utah Kidney and Hypertension, Saint George, Utah, 84770, United States|Burke Internal Medicine & Research, Burke, Virginia, 22015, United States|Clinical Research Institute of Northern Virginia, Inc., Burke, Virginia, 22015, United States|Manassas Clinical Research Center, Manassas, Virginia, 20110, United States|Zablocki Veterans Affairs Medical Center, Milwaukee, Wisconsin, 53295, United States|Centro de Salud Renal Junin S.R.L., Junin, Buenos Aires, 6000, Argentina|Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia, Mar del Plata, Buenos Aires, B7600DHK, Argentina|Instituto de Investigaciones Clinicas Quilmes S.R.L, Quilmes, Buenos Aires, B1878GEG, Argentina|Instituto de Cardiologia de Corrientes "Juana Francisca Cabral", Corrientes, W3400AMZ, Argentina|Centro de Investigaciones Clinicas del Litoral S.R.L., Santa Fe, 3000, Argentina|CETENE S.A. - Centro de Nefrologia y Dialisis, Tucumán, T4000IIO, Argentina|Liverpool Hospital, Liverpool, New South Wales, 2170, Australia|Department of Nephrology, New Lambton, New South Wales, 2305, Australia|Westmead Hospital, Department of Renal Medicine, Westmead, New South Wales, 2145, Australia|Sunshine Coast Hospital & Health Service, Nambour, Queensland, 4560, Australia|Box Hill Hospital, Box Hill, Victoria, 3128, Australia|Monash Medical Centre, Clayton, Victoria, 3168, Australia|Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia|Vancouver General Hospital, Vancouver, British Columbia, V5Z 1L8, Canada|BC Diabetes.ca, Vancouver, British Columbia, V5Z 1M9, Canada|Co-Medica Research Network Inc., Courtice, Ontario, L1E 3C3, Canada|OTT Healthcare Incorporated, Scarborough, Ontario, M1H 3G4, Canada|Dr. Stephen S. Chow Medicine Professional Corporation, Toronto, Ontario, M4C 5T2, Canada|Toronto East General Medical Centre, Toronto, Ontario, M4C 5T2, Canada|Centre de Recherche Clinique de Laval, Laval, Quebec, H7T 2P5, Canada|Hopital Maisonneuve-Rosemont-Nephrology, Montreal, Quebec, H1T 2M4, Canada|Hopital Du Sacre-Coeur de Montreal Centre de recherche, Montreal, Quebec, H4J 1C5, Canada|Pro-Recherche, St-Romuald, Quebec, G6W 5M6, Canada|Dialysezentrum Elsterland, Herzberg, Brandenburg, 04916, Germany|Studienzentrum Haematologie/Onkologie/Diabetologie, Aschaffenburg, 63739, Germany|Universitatsmedizin Berlin - Charite Campus Mitte, Berlin, 10117, Germany|GWT-TUD GmbH, Dresden, 01307, Germany|Studienzentrum Karlstrasse GmbH, Duesseldorf, 40210, Germany|Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen), Essen, 45136, Germany|Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien, Falkensee, 14612, Germany|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Nephrologisches Zentrum Hoyerswerda, Hoyerswerda, 02977, Germany|Zentrum Klinische Studien Neuwied, Neuwied, D-56564, Germany|Diabetologische Schwerpunktpraxis, Schwabenheim, 55270, Germany|Department of Medicine and Therapeutics, Prince of Wales Hospital,, Shatin, New Territories, Hong Kong SAR, Hong Kong|Department of Medicine and Therapeutics, Shatin, New Territories, Hong Kong SAR, Hong Kong|Queen Mary Hospital, Hong Kong, Hong Kong|AOU Consorziale Policlinico di Bari, Bari, BA, 70124, Italy|Ospedale Versilia, Lido Camaiore. (Lucca), Lucca, 55041, Italy|*Ospedale Versilia, Lido di Camaiore (LUCCA), Lucca, 55043, Italy|Ospedale Versilia, Lido di Camaiore (LUCCA), Lucca, 55043, Italy|A.O.U. Policlinico di Modena, Modena, MO, 41124, Italy|Azienda Ospedaliera Ospedali Riuniti di Foggia, Foggia, 71100, Italy|Ospedale Alessandro Manzoni, Lecco, 23900, Italy|Unita Cardiometabolica e Trials Clinici, Milano, 20132, Italy|Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS, Pavia, 27100, Italy|Seoul National University Hospital, Seoul, 110-744, Korea, Republic of|Yonsei University College of Medicine, Severance Hospital, Seoul, 120-752, Korea, Republic of|Chung-Ang University Hospital, Seoul, 156-755, Korea, Republic of|Hospital Universiti Sains Malaysia, Kubong Kerian, Kelantan, 16150, Malaysia|Hospital Taiping, Taiping, Perak, 34000, Malaysia|Selayang Hospital, Batu Caves, Selangor, 68100, Malaysia|Casa de Diabetes y Nutricion, Lima, 17, Peru|Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio, Lima, 27, Peru|Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL, Lima, 27, Peru|Clinica Maison de Sante ¿ Sede este, Lima, LIMA 33, Peru|Clinica Virgen Maria Auxiliadora, Piura, 073, Peru|Krakowskie Centrum Medyczne Sp. z.o.o., Krakow, Malopolskie, 31-501, Poland|Stacja Dializ, Golub-Dobrzyn, 87-400, Poland|LANDA Specjalistyczne Gabinety Lekarskie, Krakow, 30-015, Poland|SCM Sp. z.o.o, Krakow, 31-559, Poland|Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek, Lodz, 92-013, Poland|NZOZ TRI-medica, Lodz, 93-338, Poland|CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii, Warszawa, 02-507, Poland|KO-MED, Central Kliniczne Sp. z.o.o, Zamosc, 22-400, Poland|Ponce School of Medicine - CAIMED Center, Ponce, 00716, Puerto Rico|Medical Sciences Campus University of Puerto Rico, Rio Piedras, 00935, Puerto Rico|Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea, Oradea, jud. Bihor, 410469, Romania|Institutul National de Diabet, Nutritie si Boli Metabolice, Bucuresti, 020475, Romania|Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice, Ploiesti, 100018, Romania|Spitalul Clinic Judetean de Urgenta Timisoara, Timisoara, 300736, Romania|Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, 08907, Spain|Hospital Puerta de Hierro, Majadahonda, Madrid, 28222, Spain|Parc de Salut Mar. Hospital del Mar, Barcelona, 08003, Spain|Hospital Universitario Vall d'Hebron, Barcelona, 08035, Spain|Hospital Universitari de Girona Dr. Josep Trueta, Girona, 17007, Spain|Hospital Universitario Dr Peset, Valencia, 46017, Spain
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