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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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-04634817
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic nephropathy, type 2 diabetes, albuminuria, chemokine antagonist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical Investigations, Inc.
  • North America Research Institute
  • California Institute of Renal Research
  • California Kidney Specialists
  • Diabetes/Lipid Management and Research Center
  • Tower Nephrology Medical Group
  • Richard S. Cherlin, MD
  • Providence Clinical Research
  • Desert Oasis Healthcare Medical Group
  • Central Coast Nephrology
  • California Kidney Specialists
  • University of Colorado Denver/University of Colorado Hospital
  • Gulf Coast Endocrine and Diabetes Center
  • Continental Research Corp.
  • Premier Research Associate, Inc.
  • Ocean Blue Medical Research Center, Inc
  • Prestige Clinical Research Center
  • Elite Clinical Research
  • Nephrology Associates of South Miami
  • Tellus Clinical Research, Inc.
  • Diabetes Care Center
  • Gulf Coast Kidney Center
  • Suncoast Clinical Research, Inc.
  • Pines Clinical Research, Inc.
  • Christie Clinic, LLC
  • Four Rivers Clinical Research, Inc.
  • Crescent City Clinical Research Center
  • CTRC, Interim LSU Public Hospital
  • Pharmacy Department, Interim LSU Public Hospital
  • A. Kaldun Nossuli MD Research
  • Western New England Renal and Transplant Associates, PC
  • Hurley Medical Center
  • Apex Medical Research, MI, Inc.
  • Troy Internal Medicine, PC
  • Clinical Research Consultants, LLC
  • VA Medical Center
  • Creighton Diabetes Center
  • Renal Medicine Associates
  • Winthrop University Hospital, Division of Nephrology and Hypertension
  • Winthrop University Hospital, Pharmacy Department
  • Northport VA Medical Sciences Center
  • Mountain Kidney and Hypertension Associates, PA
  • East Carolina University Nephrology Research
  • Down East Medical Associates, P.A.
  • Piedmont Healthcare/Research
  • Brookview Hills Research Associates, LLC
  • Rhode Island Hospital
  • BRAHN-Hypertension and Nephrology, Inc
  • South Carolina Nephrology and Hypertension Center, Inc.
  • The Endocrine Clinic, PC
  • Nephrology Associates, P.C.
  • Independent Clinical Research
  • Clinical Trial Network
  • Southwest Nephrology Associates, LLP
  • Southwest Houston Research LTD
  • Southwest Nephrology Associates, LLP
  • Clinical Advancement Center, PLLC
  • Briggs Clinical Research, LLC
  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
  • Southwest Nephrology Associates, LLP
  • Southern Utah Kidney and Hypertension
  • Burke Internal Medicine & Research
  • Clinical Research Institute of Northern Virginia, Inc.
  • Manassas Clinical Research Center
  • Zablocki Veterans Affairs Medical Center
  • Centro de Salud Renal Junin S.R.L.
  • Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia
  • Instituto de Investigaciones Clinicas Quilmes S.R.L
  • Instituto de Cardiologia de Corrientes "Juana Francisca Cabral"
  • Centro de Investigaciones Clinicas del Litoral S.R.L.
  • CETENE S.A. - Centro de Nefrologia y Dialisis
  • Liverpool Hospital
  • Department of Nephrology
  • Westmead Hospital, Department of Renal Medicine
  • Sunshine Coast Hospital & Health Service
  • Box Hill Hospital
  • Monash Medical Centre
  • Royal Melbourne Hospital
  • Vancouver General Hospital
  • BC Diabetes.ca
  • Co-Medica Research Network Inc.
  • OTT Healthcare Incorporated
  • Dr. Stephen S. Chow Medicine Professional Corporation
  • Toronto East General Medical Centre
  • Centre de Recherche Clinique de Laval
  • Hopital Maisonneuve-Rosemont-Nephrology
  • Hopital Du Sacre-Coeur de Montreal Centre de recherche
  • Pro-Recherche
  • Dialysezentrum Elsterland
  • Studienzentrum Haematologie/Onkologie/Diabetologie
  • Universitatsmedizin Berlin - Charite Campus Mitte
  • GWT-TUD GmbH
  • Studienzentrum Karlstrasse GmbH
  • Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)
  • Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien
  • Medizinische Hochschule Hannover
  • Nephrologisches Zentrum Hoyerswerda
  • Zentrum Klinische Studien Neuwied
  • Diabetologische Schwerpunktpraxis
  • Department of Medicine and Therapeutics, Prince of Wales Hospital,
  • Department of Medicine and Therapeutics
  • Queen Mary Hospital
  • AOU Consorziale Policlinico di Bari
  • Ospedale Versilia
  • *Ospedale Versilia
  • Ospedale Versilia
  • A.O.U. Policlinico di Modena
  • Azienda Ospedaliera Ospedali Riuniti di Foggia
  • Ospedale Alessandro Manzoni
  • Unita Cardiometabolica e Trials Clinici
  • Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS
  • Seoul National University Hospital
  • Yonsei University College of Medicine, Severance Hospital
  • Chung-Ang University Hospital
  • Hospital Universiti Sains Malaysia
  • Hospital Taiping
  • Selayang Hospital
  • Casa de Diabetes y Nutricion
  • Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio
  • Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL
  • Clinica Maison de Sante ¿ Sede este
  • Clinica Virgen Maria Auxiliadora
  • Krakowskie Centrum Medyczne Sp. z.o.o.
  • Stacja Dializ
  • LANDA Specjalistyczne Gabinety Lekarskie
  • SCM Sp. z.o.o
  • Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek
  • NZOZ TRI-medica
  • CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii
  • KO-MED, Central Kliniczne Sp. z.o.o
  • Ponce School of Medicine - CAIMED Center
  • Medical Sciences Campus University of Puerto Rico
  • Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea
  • Institutul National de Diabet, Nutritie si Boli Metabolice
  • Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice
  • Spitalul Clinic Judetean de Urgenta Timisoara
  • Hospital Universitario de Bellvitge
  • Hospital Puerta de Hierro
  • Parc de Salut Mar. Hospital del Mar
  • Hospital Universitario Vall d'Hebron
  • Hospital Universitari de Girona Dr. Josep Trueta
  • Hospital Universitario Dr Peset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm 1 PF-04634817

Arm 2 Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12

Full Information

First Posted
October 19, 2012
Last Updated
September 22, 2015
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01712061
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Diabetic nephropathy, type 2 diabetes, albuminuria, chemokine antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 PF-04634817
Arm Type
Active Comparator
Arm Title
Arm 2 Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-04634817
Intervention Description
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Primary Outcome Measure Information:
Title
Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
Description
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in UACR at Weeks 4, 8 and 16
Description
The presence of albumin in the urine (macroalbuminuria) is a marker of kidney disease. Albumin and creatinine concentrations were obtained from spot urine samples.
Time Frame
Baseline, Weeks 4, 8 and 16
Title
Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16
Description
The presence of protein in the urine (proteinuria) often implies kidney disease. Protein and creatinine concentrations were obtained from spot urine samples.
Time Frame
Baseline, Weeks 4, 8, 12 and 16
Title
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
Description
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
Time Frame
Baseline, Week 1, 4, 8, 12 and 16
Title
Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16
Description
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.
Time Frame
Baseline, Week 12, and Week 16
Title
Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16
Description
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.
Time Frame
Baseline, Week 1, 4, 8, 12 and 16
Title
Change From Baseline in Serum Cystatin C at Weeks 12 and 16
Description
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.
Time Frame
Baseline, Week 12, and Week 16
Title
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16
Description
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.
Time Frame
Baseline, Weeks 4, 8, 12 and 16
Title
Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12
Time Frame
1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16
Time Frame
Baseline, Weeks 1, 4, 8, 12 and 16
Title
Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16
Time Frame
Baseline, Weeks 1, 4, 8, 12 and 16
Title
Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16
Time Frame
Baseline, Weeks 1, 4, 8, 12 and 16
Title
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
Description
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).
Time Frame
Baseline up to Week 16 (follow-up visit)
Title
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Description
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.
Time Frame
Baseline, Weeks 1, 4 and 12
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to 28 days after last study drug administration
Title
Number of Participants With Increased Fasting Blood Glucose
Time Frame
Baseline up to Week 16 (follow-up visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Medical Investigations, Inc.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
North America Research Institute
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
California Institute of Renal Research
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
California Kidney Specialists
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Diabetes/Lipid Management and Research Center
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Tower Nephrology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Richard S. Cherlin, MD
City
Los Gatos
State/Province
California
ZIP/Postal Code
95032
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Desert Oasis Healthcare Medical Group
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Central Coast Nephrology
City
Salinas
State/Province
California
ZIP/Postal Code
93901
Country
United States
Facility Name
California Kidney Specialists
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
University of Colorado Denver/University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Gulf Coast Endocrine and Diabetes Center
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Continental Research Corp.
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Premier Research Associate, Inc.
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Ocean Blue Medical Research Center, Inc
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Prestige Clinical Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Elite Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Nephrology Associates of South Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Tellus Clinical Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Diabetes Care Center
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Gulf Coast Kidney Center
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Pines Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Christie Clinic, LLC
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Crescent City Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
CTRC, Interim LSU Public Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Pharmacy Department, Interim LSU Public Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
A. Kaldun Nossuli MD Research
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Western New England Renal and Transplant Associates, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Apex Medical Research, MI, Inc.
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Troy Internal Medicine, PC
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
VA Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Creighton Diabetes Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Renal Medicine Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Winthrop University Hospital, Division of Nephrology and Hypertension
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Winthrop University Hospital, Pharmacy Department
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Northport VA Medical Sciences Center
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
Mountain Kidney and Hypertension Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
East Carolina University Nephrology Research
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Down East Medical Associates, P.A.
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Piedmont Healthcare/Research
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Brookview Hills Research Associates, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
BRAHN-Hypertension and Nephrology, Inc
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02904
Country
United States
Facility Name
South Carolina Nephrology and Hypertension Center, Inc.
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
The Endocrine Clinic, PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Nephrology Associates, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Independent Clinical Research
City
Greenville
State/Province
Texas
ZIP/Postal Code
75402
Country
United States
Facility Name
Clinical Trial Network
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Southwest Nephrology Associates, LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Southwest Houston Research LTD
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Southwest Nephrology Associates, LLP
City
Richmond
State/Province
Texas
ZIP/Postal Code
77469
Country
United States
Facility Name
Clinical Advancement Center, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Briggs Clinical Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Southwest Nephrology Associates, LLP
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Southern Utah Kidney and Hypertension
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Burke Internal Medicine & Research
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Clinical Research Institute of Northern Virginia, Inc.
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Zablocki Veterans Affairs Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States
Facility Name
Centro de Salud Renal Junin S.R.L.
City
Junin
State/Province
Buenos Aires
ZIP/Postal Code
6000
Country
Argentina
Facility Name
Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia
City
Mar del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600DHK
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Quilmes S.R.L
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878GEG
Country
Argentina
Facility Name
Instituto de Cardiologia de Corrientes "Juana Francisca Cabral"
City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Facility Name
Centro de Investigaciones Clinicas del Litoral S.R.L.
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
CETENE S.A. - Centro de Nefrologia y Dialisis
City
Tucumán
ZIP/Postal Code
T4000IIO
Country
Argentina
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Department of Nephrology
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Westmead Hospital, Department of Renal Medicine
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Sunshine Coast Hospital & Health Service
City
Nambour
State/Province
Queensland
ZIP/Postal Code
4560
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
Facility Name
BC Diabetes.ca
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Co-Medica Research Network Inc.
City
Courtice
State/Province
Ontario
ZIP/Postal Code
L1E 3C3
Country
Canada
Facility Name
OTT Healthcare Incorporated
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1H 3G4
Country
Canada
Facility Name
Dr. Stephen S. Chow Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 5T2
Country
Canada
Facility Name
Toronto East General Medical Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 5T2
Country
Canada
Facility Name
Centre de Recherche Clinique de Laval
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont-Nephrology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital Du Sacre-Coeur de Montreal Centre de recherche
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Pro-Recherche
City
St-Romuald
State/Province
Quebec
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
Dialysezentrum Elsterland
City
Herzberg
State/Province
Brandenburg
ZIP/Postal Code
04916
Country
Germany
Facility Name
Studienzentrum Haematologie/Onkologie/Diabetologie
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Universitatsmedizin Berlin - Charite Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GWT-TUD GmbH
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Studienzentrum Karlstrasse GmbH
City
Duesseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien
City
Falkensee
ZIP/Postal Code
14612
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Nephrologisches Zentrum Hoyerswerda
City
Hoyerswerda
ZIP/Postal Code
02977
Country
Germany
Facility Name
Zentrum Klinische Studien Neuwied
City
Neuwied
ZIP/Postal Code
D-56564
Country
Germany
Facility Name
Diabetologische Schwerpunktpraxis
City
Schwabenheim
ZIP/Postal Code
55270
Country
Germany
Facility Name
Department of Medicine and Therapeutics, Prince of Wales Hospital,
City
Shatin, New Territories
State/Province
Hong Kong SAR
Country
Hong Kong
Facility Name
Department of Medicine and Therapeutics
City
Shatin, New Territories
State/Province
Hong Kong SAR
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
AOU Consorziale Policlinico di Bari
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale Versilia
City
Lido Camaiore. (Lucca)
State/Province
Lucca
ZIP/Postal Code
55041
Country
Italy
Facility Name
*Ospedale Versilia
City
Lido di Camaiore (LUCCA)
State/Province
Lucca
ZIP/Postal Code
55043
Country
Italy
Facility Name
Ospedale Versilia
City
Lido di Camaiore (LUCCA)
State/Province
Lucca
ZIP/Postal Code
55043
Country
Italy
Facility Name
A.O.U. Policlinico di Modena
City
Modena
State/Province
MO
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliera Ospedali Riuniti di Foggia
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Ospedale Alessandro Manzoni
City
Lecco
ZIP/Postal Code
23900
Country
Italy
Facility Name
Unita Cardiometabolica e Trials Clinici
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University College of Medicine, Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
156-755
Country
Korea, Republic of
Facility Name
Hospital Universiti Sains Malaysia
City
Kubong Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Selayang Hospital
City
Batu Caves
State/Province
Selangor
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Casa de Diabetes y Nutricion
City
Lima
ZIP/Postal Code
17
Country
Peru
Facility Name
Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Clinica Maison de Sante ¿ Sede este
City
Lima
ZIP/Postal Code
LIMA 33
Country
Peru
Facility Name
Clinica Virgen Maria Auxiliadora
City
Piura
ZIP/Postal Code
073
Country
Peru
Facility Name
Krakowskie Centrum Medyczne Sp. z.o.o.
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Stacja Dializ
City
Golub-Dobrzyn
ZIP/Postal Code
87-400
Country
Poland
Facility Name
LANDA Specjalistyczne Gabinety Lekarskie
City
Krakow
ZIP/Postal Code
30-015
Country
Poland
Facility Name
SCM Sp. z.o.o
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek
City
Lodz
ZIP/Postal Code
92-013
Country
Poland
Facility Name
NZOZ TRI-medica
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
KO-MED, Central Kliniczne Sp. z.o.o
City
Zamosc
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Ponce School of Medicine - CAIMED Center
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Facility Name
Medical Sciences Campus University of Puerto Rico
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea
City
Oradea
State/Province
jud. Bihor
ZIP/Postal Code
410469
Country
Romania
Facility Name
Institutul National de Diabet, Nutritie si Boli Metabolice
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice
City
Ploiesti
ZIP/Postal Code
100018
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Timisoara
City
Timisoara
ZIP/Postal Code
300736
Country
Romania
Facility Name
Hospital Universitario de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Parc de Salut Mar. Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universitario Dr Peset
City
Valencia
ZIP/Postal Code
46017
Country
Spain

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1261007&StudyName=A%20Phase%202%20Multi-Center%20Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20A%20Chemokine%20CCR2/5%20Receptor%20Antagonist%20In%20Adults%20With%20Type%202%20D
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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