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
NCT ID: NCT01712061
Last Updated: 2015-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2012-12-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1 PF-04634817
PF-04634817
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Arm 2 Placebo
Placebo
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Interventions
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PF-04634817
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Placebo
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Medical Investigations, Inc.
Little Rock, Arkansas, United States
North America Research Institute
Azusa, California, United States
California Institute of Renal Research
Chula Vista, California, United States
California Kidney Specialists
Covina, California, United States
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States
Tower Nephrology Medical Group
Los Angeles, California, United States
Richard S. Cherlin, MD
Los Gatos, California, United States
Providence Clinical Research
North Hollywood, California, United States
Desert Oasis Healthcare Medical Group
Palm Springs, California, United States
Central Coast Nephrology
Salinas, California, United States
California Kidney Specialists
San Dimas, California, United States
University of Colorado Denver/University of Colorado Hospital
Aurora, Colorado, United States
Gulf Coast Endocrine and Diabetes Center
Clearwater, Florida, United States
Continental Research Corp.
Doral, Florida, United States
Premier Research Associate, Inc.
Hialeah, 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
Tellus Clinical Research, Inc.
Miami, Florida, United States
Ocean Blue Medical Research Center, Inc
Miami Springs, 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
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States
Christie Clinic, LLC
Champaign, Illinois, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Crescent City Clinical Research Center
Metairie, Louisiana, United States
CTRC, Interim LSU Public Hospital
New Orleans, Louisiana, United States
Pharmacy Department, Interim LSU Public Hospital
New Orleans, Louisiana, United States
A. Kaldun Nossuli MD Research
Bethesda, Maryland, United States
Western New England Renal and Transplant Associates, PC
Springfield, Massachusetts, United States
Hurley Medical Center
Flint, Michigan, United States
Apex Medical Research, MI, Inc.
Flint, Michigan, United States
Troy Internal Medicine, PC
Troy, Michigan, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, United States
VA Medical Center
Kansas City, Missouri, United States
Creighton Diabetes Center
Omaha, Nebraska, United States
Renal Medicine Associates
Albuquerque, New Mexico, United States
Winthrop University Hospital, Division of Nephrology and Hypertension
Mineola, New York, United States
Winthrop University Hospital, Pharmacy Department
Mineola, New York, United States
Northport VA Medical Sciences Center
Northport, New York, United States
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, United States
East Carolina University Nephrology Research
Greenville, North Carolina, United States
Down East Medical Associates, P.A.
Morehead City, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States
Rhode Island Hospital
Providence, Rhode Island, United States
BRAHN-Hypertension and Nephrology, Inc
Providence, Rhode Island, United States
South Carolina Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, United States
The Endocrine Clinic, PC
Memphis, Tennessee, United States
Nephrology Associates, P.C.
Nashville, Tennessee, United States
Independent Clinical Research
Greenville, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Southwest Nephrology Associates, LLP
Houston, Texas, United States
Southwest Houston Research LTD
Houston, Texas, United States
Southwest Nephrology Associates, LLP
Richmond, Texas, 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
Southwest Nephrology Associates, LLP
Sugar Land, Texas, United States
Southern Utah Kidney and Hypertension
St. George, Utah, United States
Burke Internal Medicine & Research
Burke, Virginia, United States
Clinical Research Institute of Northern Virginia, Inc.
Burke, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, United States
Centro de Salud Renal Junin S.R.L.
Junín, Buenos Aires, 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
San Miguel de Tucumán, , Argentina
Centro de Investigaciones Clinicas del Litoral S.R.L.
Santa Fe, , Argentina
Liverpool Hospital
Liverpool, New South Wales, Australia
Department of Nephrology
New Lambton, New South Wales, Australia
Westmead Hospital, Department of Renal Medicine
Westmead, New South Wales, Australia
Sunshine Coast Hospital & Health Service
Nambour, Queensland, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Vancouver General Hospital
Vancouver, British Columbia, Canada
BC Diabetes.ca
Vancouver, British Columbia, Canada
Co-Medica Research Network Inc.
Courtice, Ontario, Canada
OTT Healthcare Incorporated
Scarborough Village, Ontario, Canada
Dr. Stephen S. Chow Medicine Professional Corporation
Toronto, Ontario, Canada
Toronto East General Medical Centre
Toronto, Ontario, Canada
Centre de Recherche Clinique de Laval
Laval, Quebec, Canada
Hopital Maisonneuve-Rosemont-Nephrology
Montreal, Quebec, Canada
Hopital Du Sacre-Coeur de Montreal Centre de recherche
Montreal, Quebec, Canada
Pro-Recherche
Saint Romuald, Quebec, Canada
Dialysezentrum Elsterland
Herzberg, Brandenburg, Germany
Studienzentrum Haematologie/Onkologie/Diabetologie
Aschaffenburg, , Germany
Universitatsmedizin Berlin - Charite Campus Mitte
Berlin, , Germany
GWT-TUD GmbH
Dresden, , Germany
Studienzentrum Karlstrasse GmbH
Düsseldorf, , Germany
Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)
Essen, , Germany
Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien
Falkensee, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Nephrologisches Zentrum Hoyerswerda
Hoyerswerda, , Germany
Zentrum Klinische Studien Neuwied
Neuwied, , Germany
Diabetologische Schwerpunktpraxis
Schwabenheim, , 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, Italy
Ospedale Alessandro Manzoni
Lecco, Italy, Italy
Ospedale Versilia
Lido Camaiore. (Lucca), Lucca, Italy
*Ospedale Versilia
Lido Di Camaiore (lucca), Lucca, Italy
Ospedale Versilia
Lido Di Camaiore (lucca), Lucca, Italy
A.O.U. Policlinico di Modena
Modena, MO, Italy
Azienda Ospedaliera Ospedali Riuniti di Foggia
Foggia, , Italy
Unita Cardiometabolica e Trials Clinici
Milan, , Italy
Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS
Pavia, , Italy
Hospital Universiti Sains Malaysia
Kubong Kerian, Kelantan, Malaysia
Hospital Taiping
Taiping, Perak, Malaysia
Selayang Hospital
Batu Caves, Selangor, Malaysia
Casa de Diabetes y Nutricion
Lima, Lima Province, Peru
Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL
Lima, Lima Province, 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, Lesser Poland Voivodeship, Poland
Stacja Dializ
Golub-Dobrzyń, , 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
Warsaw, , Poland
KO-MED, Central Kliniczne Sp. z.o.o
Zamość, , Poland
Ponce School of Medicine - CAIMED Center
Ponce, , Puerto Rico
Medical Sciences Campus University of Puerto Rico
Rio Piedras, , Puerto Rico
Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea
Oradea, Jud. Bihor, Romania
Institutul National de Diabet, Nutritie si Boli Metabolice
Bucharest, , Romania
Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice
Ploieşti, , Romania
Spitalul Clinic Judetean de Urgenta Timisoara
Timișoara, , Romania
Seoul National University Hospital
Seoul, , South Korea
Yonsei University College of Medicine, Severance Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Parc de Salut Mar. Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, , Spain
Hospital Universitario Dr Peset
Valencia, , Spain
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2012-003332-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1261007
Identifier Type: -
Identifier Source: org_study_id
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