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
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
2 other identifiers
interventional
226
14 countries
142
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 23, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
October 21, 2015
CompletedOctober 21, 2015
September 1, 2015
1.8 years
October 19, 2012
September 22, 2015
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
Change From Baseline in UACR at Weeks 4, 8 and 16
Baseline, Weeks 4, 8 and 16
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16
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
Baseline, Week 1, 4, 8, 12 and 16
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16
Baseline, Week 12, and Week 16
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16
Baseline, Week 1, 4, 8, 12 and 16
- +3 more secondary outcomes
Other Outcomes (7)
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
- +4 more other outcomes
Study Arms (2)
Arm 1 PF-04634817
ACTIVE COMPARATORArm 2 Placebo
PLACEBO COMPARATORInterventions
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (142)
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
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
Ocean Blue Medical Research Center, Inc
Miami Springs, Florida, 33166, 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
St. 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.
Junín, 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
CETENE S.A. - Centro de Nefrologia y Dialisis
San Miguel de Tucumán, T4000IIO, Argentina
Centro de Investigaciones Clinicas del Litoral S.R.L.
Santa Fe, 3000, 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 Village, 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
Saint 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
Düsseldorf, 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
Hanover, 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 Alessandro Manzoni
Lecco, Italy, 23900, 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
Unita Cardiometabolica e Trials Clinici
Milan, 20132, Italy
Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS
Pavia, 27100, Italy
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, Lima Province, 17, Peru
Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL
Lima, Lima Province, 27, Peru
Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio
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, Lesser Poland Voivodeship, 31-501, Poland
Stacja Dializ
Golub-Dobrzyń, 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
Warsaw, 02-507, Poland
KO-MED, Central Kliniczne Sp. z.o.o
Zamość, 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
Bucharest, 020475, Romania
Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice
Ploieşti, 100018, Romania
Spitalul Clinic Judetean de Urgenta Timisoara
Timișoara, 300736, Romania
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei University College of Medicine, Severance Hospital
Seoul, 120-752, South Korea
Chung-Ang University Hospital
Seoul, 156-755, South Korea
Hospital Universitario de Bellvitge
L'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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 23, 2012
Study Start
December 1, 2012
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 21, 2015
Results First Posted
October 21, 2015
Record last verified: 2015-09