A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy
- Registration Number
- NCT01712061
- Lead Sponsor
- Pfizer
- Brief Summary
The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
- Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2.
- Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9 mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
- Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.
- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo Placebo - Arm 1 PF-04634817 PF-04634817 -
- Primary Outcome Measures
Name Time Method Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12 Baseline and 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.
- Secondary Outcome Measures
Name Time Method 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 Baseline, Week 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
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16 Baseline, 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.
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16 Baseline, Week 12, and Week 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.
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 Change From Baseline in UACR at Weeks 4, 8 and 16 Baseline, 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.
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16 Baseline, Week 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.
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16 Baseline, 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.
Change From Baseline in Serum Cystatin C at Weeks 12 and 16 Baseline, Week 12, and Week 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.
Trial Locations
- Locations (138)
Co-Medica Research Network Inc.
🇨🇦Courtice, Ontario, Canada
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Clinical Trial Network
🇺🇸Houston, Texas, United States
Southwest Houston Research LTD
🇺🇸Houston, Texas, United States
Liverpool Hospital
🇦🇺Liverpool, New South Wales, Australia
Toronto East General Medical Centre
🇨🇦Toronto, Ontario, Canada
Dr. Stephen S. Chow Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Centro de Salud Renal Junin S.R.L.
🇦🇷Junin, Buenos Aires, Argentina
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Nephrologisches Zentrum Hoyerswerda
🇩🇪Hoyerswerda, Germany
A.O.U. Policlinico di Modena
🇮🇹Modena, MO, Italy
Unita Cardiometabolica e Trials Clinici
🇮🇹Milano, Italy
KO-MED, Central Kliniczne Sp. z.o.o
🇵🇱Zamosc, Poland
Ponce School of Medicine - CAIMED Center
🇵🇷Ponce, Puerto Rico
North America Research Institute
🇺🇸Azusa, California, United States
California Kidney Specialists
🇺🇸San Dimas, California, United States
Tower Nephrology Medical Group
🇺🇸Los Angeles, California, United States
Gulf Coast Endocrine and Diabetes Center
🇺🇸Clearwater, Florida, United States
Continental Research Corp.
🇺🇸Doral, Florida, United States
Prestige Clinical Research Center
🇺🇸Miami, Florida, United States
Elite Clinical Research
🇺🇸Miami, Florida, United States
Nephrology Associates of South Miami
🇺🇸Miami, Florida, United States
Pines Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Apex Medical Research, MI, Inc.
🇺🇸Flint, Michigan, United States
Mountain Kidney and Hypertension Associates, PA
🇺🇸Asheville, North Carolina, United States
East Carolina University Nephrology Research
🇺🇸Greenville, North Carolina, United States
Piedmont Healthcare/Research
🇺🇸Statesville, North Carolina, United States
Department of Nephrology
🇦🇺New Lambton, New South Wales, Australia
Nephrology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
Clinical Advancement Center, PLLC
🇺🇸San Antonio, Texas, United States
Briggs Clinical Research, LLC
🇺🇸San Antonio, Texas, United States
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
🇺🇸San Antonio, Texas, United States
*Ospedale Versilia
🇮🇹Lido di Camaiore (LUCCA), Lucca, Italy
Hospital Puerta de Hierro
🇪🇸Majadahonda, Madrid, Spain
Ospedale Versilia
🇮🇹Lido di Camaiore (LUCCA), Lucca, Italy
Creighton Diabetes Center
🇺🇸Omaha, Nebraska, United States
Zablocki Veterans Affairs Medical Center
🇺🇸Milwaukee, Wisconsin, United States
A. Kaldun Nossuli MD Research
🇺🇸Bethesda, Maryland, United States
California Institute of Renal Research
🇺🇸Chula Vista, California, United States
Medical Investigations, Inc.
🇺🇸Little Rock, Arkansas, United States
Richard S. Cherlin, MD
🇺🇸Los Gatos, California, United States
Diabetes/Lipid Management and Research Center
🇺🇸Huntington Beach, California, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Central Coast Nephrology
🇺🇸Salinas, California, United States
Desert Oasis Healthcare Medical Group
🇺🇸Palm Springs, California, United States
Premier Research Associate, Inc.
🇺🇸Hialeah, Florida, United States
Ocean Blue Medical Research Center, Inc
🇺🇸Miami Springs, Florida, United States
Tellus Clinical Research, Inc.
🇺🇸Miami, Florida, United States
Diabetes Care Center
🇺🇸New Port Richey, Florida, United States
Gulf Coast Kidney Center
🇺🇸New Port Richey, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Christie Clinic, LLC
🇺🇸Champaign, Illinois, United States
Crescent City Clinical Research Center
🇺🇸Metairie, Louisiana, United States
Western New England Renal and Transplant Associates, PC
🇺🇸Springfield, Massachusetts, United States
Renal Medicine Associates
🇺🇸Albuquerque, New Mexico, United States
Winthrop University Hospital, Division of Nephrology and Hypertension
🇺🇸Mineola, New York, United States
Troy Internal Medicine, PC
🇺🇸Troy, Michigan, United States
Winthrop University Hospital, Pharmacy Department
🇺🇸Mineola, New York, United States
Northport VA Medical Sciences Center
🇺🇸Northport, New York, United States
Down East Medical Associates, P.A.
🇺🇸Morehead City, North Carolina, United States
BRAHN-Hypertension and Nephrology, Inc
🇺🇸Providence, Rhode Island, United States
The Endocrine Clinic, PC
🇺🇸Memphis, Tennessee, United States
South Carolina Nephrology and Hypertension Center, Inc.
🇺🇸Orangeburg, South Carolina, United States
Independent Clinical Research
🇺🇸Greenville, Texas, United States
Southwest Nephrology Associates, LLP
🇺🇸Sugar Land, Texas, United States
Clinical Research Institute of Northern Virginia, Inc.
🇺🇸Burke, Virginia, United States
Southern Utah Kidney and Hypertension
🇺🇸Saint George, Utah, United States
Burke Internal Medicine & Research
🇺🇸Burke, Virginia, United States
Manassas Clinical Research Center
🇺🇸Manassas, Virginia, United States
Centro de Investigaciones Clinicas del Litoral S.R.L.
🇦🇷Santa Fe, Argentina
Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia
🇦🇷Mar del Plata, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Quilmes S.R.L
🇦🇷Quilmes, Buenos Aires, Argentina
Instituto de Cardiologia de Corrientes "Juana Francisca Cabral"
🇦🇷Corrientes, Argentina
CETENE S.A. - Centro de Nefrologia y Dialisis
🇦🇷Tucumán, Argentina
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Westmead Hospital, Department of Renal Medicine
🇦🇺Westmead, New South Wales, Australia
Sunshine Coast Hospital & Health Service
🇦🇺Nambour, Queensland, Australia
BC Diabetes.ca
🇨🇦Vancouver, British Columbia, Canada
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Centre de Recherche Clinique de Laval
🇨🇦Laval, Quebec, Canada
OTT Healthcare Incorporated
🇨🇦Scarborough, Ontario, Canada
Hopital Maisonneuve-Rosemont-Nephrology
🇨🇦Montreal, Quebec, Canada
Pro-Recherche
🇨🇦St-Romuald, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal Centre de recherche
🇨🇦Montreal, Quebec, Canada
Dialysezentrum Elsterland
🇩🇪Herzberg, Brandenburg, Germany
Studienzentrum Haematologie/Onkologie/Diabetologie
🇩🇪Aschaffenburg, Germany
Universitatsmedizin Berlin - Charite Campus Mitte
🇩🇪Berlin, Germany
Studienzentrum Karlstrasse GmbH
🇩🇪Duesseldorf, Germany
Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)
🇩🇪Essen, Germany
GWT-TUD GmbH
🇩🇪Dresden, Germany
Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien
🇩🇪Falkensee, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Department of Medicine and Therapeutics, Prince of Wales Hospital,
ðŸ‡ðŸ‡°Shatin, New Territories, Hong Kong SAR, Hong Kong
Department of Medicine and Therapeutics
ðŸ‡ðŸ‡°Shatin, New Territories, Hong Kong SAR, Hong Kong
Zentrum Klinische Studien Neuwied
🇩🇪Neuwied, Germany
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
Diabetologische Schwerpunktpraxis
🇩🇪Schwabenheim, Germany
AOU Consorziale Policlinico di Bari
🇮🇹Bari, BA, Italy
Ospedale Alessandro Manzoni
🇮🇹Lecco, Italy
Azienda Ospedaliera Ospedali Riuniti di Foggia
🇮🇹Foggia, Italy
Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS
🇮🇹Pavia, Italy
Hospital Universiti Sains Malaysia
🇲🇾Kubong Kerian, Kelantan, Malaysia
Yonsei University College of Medicine, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Hospital Taiping
🇲🇾Taiping, Perak, Malaysia
Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL
🇵🇪Lima, Peru
Selayang Hospital
🇲🇾Batu Caves, Selangor, Malaysia
Casa de Diabetes y Nutricion
🇵🇪Lima, Peru
Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio
🇵🇪Lima, Peru
Clinica Maison de Sante ¿ Sede este
🇵🇪Lima, Peru
Clinica Virgen Maria Auxiliadora
🇵🇪Piura, Peru
Krakowskie Centrum Medyczne Sp. z.o.o.
🇵🇱Krakow, Malopolskie, Poland
Stacja Dializ
🇵🇱Golub-Dobrzyn, Poland
LANDA Specjalistyczne Gabinety Lekarskie
🇵🇱Krakow, Poland
SCM Sp. z.o.o
🇵🇱Krakow, Poland
Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek
🇵🇱Lodz, Poland
NZOZ TRI-medica
🇵🇱Lodz, Poland
CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii
🇵🇱Warszawa, Poland
Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea
🇷🇴Oradea, jud. Bihor, Romania
Medical Sciences Campus University of Puerto Rico
🇵🇷Rio Piedras, Puerto Rico
Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice
🇷🇴Ploiesti, Romania
Spitalul Clinic Judetean de Urgenta Timisoara
🇷🇴Timisoara, Romania
Institutul National de Diabet, Nutritie si Boli Metabolice
🇷🇴Bucuresti, Romania
Hospital Universitario de Bellvitge
🇪🇸Hospitalet de Llobregat, Barcelona, Spain
Parc de Salut Mar. Hospital del Mar
🇪🇸Barcelona, Spain
Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Dr Peset
🇪🇸Valencia, Spain
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
University of Colorado Denver/University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Clinical Research Consultants, LLC
🇺🇸Kansas City, Missouri, United States
VA Medical Center
🇺🇸Kansas City, Missouri, United States
Brookview Hills Research Associates, LLC
🇺🇸Winston-Salem, North Carolina, United States
CTRC, Interim LSU Public Hospital
🇺🇸New Orleans, Louisiana, United States
Pharmacy Department, Interim LSU Public Hospital
🇺🇸New Orleans, Louisiana, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States