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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01712061
First received: October 19, 2012
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Nephropathy
Drug: PF-04634817
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Urinary albumin:creatinine ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary albumin:creatinine ratio [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Urinary albumin:creatinine ratio [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Urinary albumin:creatinine ratio [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Urinary protein:creatinine ratio [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Urinary protein:creatinine ratio [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Urinary protein:creatinine ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Urinary protein:creatinine ratio [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) using the abbreviated (4 variable) Modification of Diet in Renal Disease (MDRD) formula [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) using the eGFRcystatin formula [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Estimated glomerular filtration rate (eGFR) using the eGFRcystatin formula [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serum creatinine [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Serum cystatin C [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Serum cystatin C [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Plasma glycosylated hemoglobin [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Plasma glycosylated hemoglobin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma glycosylated hemoglobin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Plasma glycosylated hemoglobin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 226
Study Start Date: December 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 PF-04634817 Drug: PF-04634817
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Placebo Comparator: Arm 2 Placebo Drug: Placebo
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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: NCT01712061

  Hide Study Locations
Locations
United States, Arkansas
Medical Investigations, Inc.
Little Rock, Arkansas, United States, 72205
United States, California
North American Research Institute
Azusa, California, United States, 91702
California Institute of Renal Research
Chula Vista, California, United States, 91910
Diabetes/Lipid Management and Research Center
Huntington Beach, California, United States, 92648
Diabetes/Lipid Management & Research Center
Laguna Niguel, California, United States, 92667
Tower Nephrology Medical Group
Los Angeles, California, United States, 90048
The Office of Richard S. Cherlin, MD
Los Gatos, California, United States, 95032
Providence Clinical Research
North Hollywood, California, United States, 91606
Desert Medical Group,Inc. dba Desert Oasis Healthcare Medical Group
Palm Springs, California, United States, 92262
Central Coast Nephrology
Salinas, California, United States, 93901
United States, Colorado
University of Colorado Denver/University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Florida
Gulf Coast Endocrine and Diabetes Center
Clearwater, Florida, United States, 33756
Continental Research Corp.
Doral, Florida, United States, 33126
Premier Research Associate, Inc.
Hialeah, Florida, United States, 33012
Nephrology Associates of South Miami
Miami, Florida, United States, 33173
Continental Research
Miami, Florida, United States, 33155
Elite Clinical Research
Miami, Florida, United States, 33144
Prestige Clinical Research Center
Miami, Florida, United States, 33133
Tellus Clinical Research, Inc.
Miami, Florida, United States, 33173
Ocean Blue Medical Research Center, Inc
Miami Springs, Florida, United States, 33166
Diabetes Care Center
New Port Richey, Florida, United States, 34652
Gulf Coast Kidney Center
New Port Richey, Florida, United States, 34652
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Pines Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33028
United States, Illinois
Apex Medical Research, AMR, INC
Burr Ridge, Illinois, United States, 60527
Christie Clinic, LLC
Champaign, Illinois, United States, 61822
Christie Clinic, LLC
Champaign, Illinois, United States, 61820
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
CTRC, Interim LSU Public Hospital
New Orleans, Louisiana, United States, 70112
Pharmacy Department, Interim LSU Public Hospital
New Orleans, Louisiana, United States, 70112
United States, Maryland
A. Kaldun Nossuli, MD /Research
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Western New England Renal and Transplant Associates, PC
Springfield, Massachusetts, United States, 01107
United States, Michigan
Apex Medical Research, MI, Inc.
Flint, Michigan, United States, 48504
Hurley Medical Center
Flint, Michigan, United States, 48503
Troy Internal Medicine, PC
Troy, Michigan, United States, 48098
United States, Missouri
Clinical Research Consultants, LLC
Kansas City, Missouri, United States, 64111
VA Medical Center
Kansas City, Missouri, United States, 64128
United States, Nebraska
Creighton Diabetes Center
Omaha, Nebraska, United States, 68131
United States, New Mexico
Renal Medicine Associates
Albuquerque, New Mexico, United States, 87109
United States, New York
Winthrop University Hospital, Division of Nephrology and Hypertension
Mineola, New York, United States, 11501
Winthrop University Hospital, Pharmacy Department
Mineola, New York, United States, 11501
Northport VA Medical Center
Northport, New York, United States, 11768
United States, North Carolina
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, United States, 28801
East Carolina University Nephrology Research
Greenville, North Carolina, United States, 27834
Brody School of Medicine
Greenville, North Carolina, United States, 27834
Moye Medical Center 1
Greenville, North Carolina, United States, 27834
Down East Medical Associates, P.A.
Morehead City, North Carolina, United States, 28557
Piedmont Healthcare/Research
Statesville, North Carolina, United States, 28625
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States, 27103
United States, Rhode Island
BRAHN-Hypertension and Nephrology, Inc
Providence, Rhode Island, United States, 02904
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
South Carolina Nephrology and Hypertension Center, Inc.
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
The Endocrine Clinic, PC
Memphis, Tennessee, United States, 38119
Nephrology Associates, PC
Nashville, Tennessee, United States, 37205
United States, Texas
Independent Clinical Research
Greenville, Texas, United States, 75402
Clinical Trial Network
Houston, Texas, United States, 77074
Southwest Houston Research LTD
Houston, Texas, United States, 77099
Southwest Nephrology Associates, LLP
Houston, Texas, United States, 77074
Southwest Nephrology Associates, LLP
Richmond, Texas, United States, 77469
Briggs Clinical Research, LLC
San Antonio, Texas, United States, 78224
Clinical Advancement Center
San Antonio, Texas, United States, 78215
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
San Antonio, Texas, United States, 78229
Southwest Nephrology Associates, LLP
Sugar Land, Texas, United States, 77478
United States, Utah
Southern Utah Kidney and Hypertension Center
Saint George, Utah, United States, 84770
United States, Virginia
Clinical Research Institute of Northern Virginia
Burke, Virginia, United States, 22015-4202
Burke Internal Medicine & Research
Burke, Virginia, United States, 22015
Manassas Clinical Research Center
Manassas, Virginia, United States, 20110
United States, Wisconsin
Zablocki Veterans Affairs Medical Center
Milwaukee, Wisconsin, United States, 53295
Argentina
Centro de Salud Renal Junin S.R.L.
Junin, Buenos Aires, Argentina, 6000
Centro de Investigaciones Medicas "Clinica de Fractura y Ortopedia"
Mar del Plata, Buenos Aires, Argentina, B7600DHK
Instituto de Investigaciones Clinicas Quilmes S.R.L
Quilmes, Buenos Aires, Argentina, B1878GEG
Instituto de Cardiologia de Corrientes "Juana Francisca Cabral"
Corrientes, Argentina, W3400AMZ
Centro de Investigaciones Clinicas del Litoral
Santa Fe, Argentina, 3000
CETENE S.A. - Centro de Nefrologia y Dialisis
Tucumán, Argentina, T4000IIO
Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Department of Nephrology
New Lambton, New South Wales, Australia, 2305
Westmead Hospital, Department of Renal Medicine
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Sunshine Coast Hospital & Health Service
Nambour, Queensland, Australia, 4560
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Canada, British Columbia
BC Diabetes.ca
Vancouver, British Columbia, Canada, V5Z 1L8
BC Diabetes.ca
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
Co-Medica Research Network Inc., Courtice Health Centre
Courtice, Ontario, Canada, L1E 3C3
Co-Medica Research Network Inc.
Courtice, Ontario, Canada, L1E 3C3
OTT Healthcare Inc., Corporate Medical Centre
Scarborough, Ontario, Canada, M1H 3G4
Dr. Stephen S. Chow Medicine Professional Corporation
Toronto, Ontario, Canada, M4C 5T2
Canada, Quebec
Centre de Recherche Clinique de Laval
Laval, Quebec, Canada, H7T 2P5
Hopital Du Sacre-Coeur de Montreal Centre de recherche
Montreal, Quebec, Canada, H4J 1C5
Hopital Maisonneuve-Rosemont-Nephrology
Montreal, Quebec, Canada, H1T 2M4
Pro-Recherche
St-Romuald, Quebec, Canada, G6W 5M6
Germany
Dialysezentrum Elsterland
Herzberg, Brandenburg, Germany, 04916
Studienzentrum Karlstrasse GmbH
Duesseldorf, NRW, Germany, 40210
Nephrologisches Zentrum Hoyerswerda
Hoyerswerda, Saxony, Germany, 02977
Studienzentrum
Aschaffenburg, Germany, 63739
Universitatsmedizin Berlin - Charite Campus Mitte
Berlin, Germany, 10117
GWT-TUD GmbH
Dresden, Germany, 01307
Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)
Essen, Germany, 45136
Diabetes Schwerpunktpraxis / Zentrum fuer Klinische Studien
Falkensee, Germany, 14612
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Zentrum Klinische Studien Neuwied
Neuwied, Germany, D-56564
Diabetologische Schwerpunktpraxis
Schwabenheim, Germany, 55270
Hong Kong
Department of Medicine and Therapeutics
Shatin, New Territories, Hong Kong SAR, Hong Kong
Department of Medicine and Therapeutics, Prince of Wales Hospital,
Shatin, New Territories, Hong Kong SAR, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Italy
AOU Consorziale Policlinico di Bari
Bari, BA, Italy, 70124
Ospedale San Raffaele
Milano, MI, Italy, 20132
A.O.U. Policlinico di Modena
Modena, MO, Italy, 41124
Azienda Ospedaliera Ospedali Riuniti di Foggia
Foggia, Italy, 71100
Alessandro Manzoni Hospital
Lecco, Italy, 23900
Ospedale Versilia/AUSL12 Viareggio
Lido Camaiore. (Lucca), Italy, 55041
Servizio di Farmacia
Milano, Italy, 20132
Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS
Pavia, Italy, 27100
Korea, Republic of
Chung-Ang University Hospital
Seoul, Korea, Republic of, 156-755
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Yonsei University College of Medicine, Severance Hospital
Seoul, Korea, Republic of, 120-752
Malaysia
Hospital Universiti Sains Malaysia
Kubong Kerian, Kelantan, Malaysia, 16150
Hospital Taiping
Taiping, Perak, Malaysia, 34000
Selayang Hospital
Batu Caves, Selangor, Malaysia, 68100
Peru
Casa de Diabetes y Nutricion
Lima, Peru, 17
Centro de Investigacion y Atencion Cardiovascular S.A.C. - Novocardio
Lima, Peru, 27
Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL
Lima, Peru, 27
Centro de Investigacion de Piura
Piura, Peru, 073
Clínica Maison de Sante del Este
Santiago de Surco, Peru, LIMA 33
Poland
NZOZ TRI-medica
Lodz, Lodzkie, Poland, 93-338
KO-MED, Centra Kliniczne
Zamosc, Lubelskie, Poland, 22-400
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, Malopolska, Poland, 30-015
Krakowskie Centrum Medyczne Sp. z.o.o.
Krakow, Malopolskie, Poland, 31-501
Stacja Dializ
Golub-Dobrzyn, Poland, 87-400
Specjalistyczne Centrum SCM Sp. z o o
Krakow, Poland, 31-559
Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek
Lodz, Poland, 92-013
NZOZ Trimedica - Legal Dept
Lodz, Poland, 93-428
CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii
Warszawa, Poland, 02-507
Puerto Rico
Ponce School of Medicine - CAIMED Center
Ponce, Puerto Rico, 00716
Medical Sciences Campus University of Puerto Rico
Rio Piedras, Puerto Rico, 00935
Romania
Covance Central Laboratory Services, Inc.
Indianapolis, IN, Romania, 46214
Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea
Oradea, jud. Bihor, Romania, 410469
Institutul National de Diabet, Nutritie si Boli Metabolice
Bucuresti, Romania, 020475
Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice
Ploiesti, Romania, 100018
Spitalul Clinic Judetean de Urgenta Timisoara
Timisoara, Romania, 300736
Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Hospital Puerta de Hierro
Madrid, Majadahonda, Spain, 28222
Hospital Universitario de Bellvitge Carrer de la Feixa Llarga
Barcelona, Spain, 08907
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Parc de Salut Mar
Barcelona, Spain, 08003
Parc de Salut Mar-Hospital del Mar
Barcelona, Spain, 08003
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Spain, 17007
Hospital Universitario Dr Peset
Valencia, Spain, 46017
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01712061     History of Changes
Other Study ID Numbers: B1261007, 2012-003332-23
Study First Received: October 19, 2012
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Diabetic nephropathy
type 2 diabetes
albuminuria
chemokine antagonist

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetic Nephropathies
Kidney Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014