Clinical trial NCT01712061: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic nephropathy
type 2 diabetes
albuminuria
chemokine antagonist
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change From Baseline in UACR at Weeks 4, 8 and 16
timeFrame: Baseline, Weeks 4, 8 and 16
measure: Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 4, 8, 12 and 16
timeFrame: Baseline, Weeks 4, 8, 12 and 16
measure: 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
timeFrame: Baseline, Week 1, 4, 8, 12 and 16
measure: Change From Baseline in eGFR Using Cystatin Formula at Weeks 12 and 16
timeFrame: Baseline, Week 12, and Week 16
measure: Change From Baseline in Serum Creatinine at Weeks 1, 4, 8, 12 and 16
timeFrame: Baseline, Week 1, 4, 8, 12 and 16
measure: Change From Baseline in Serum Cystatin C at Weeks 12 and 16
timeFrame: Baseline, Week 12, and Week 16
measure: Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) at Weeks 4, 8, 12 and 16
timeFrame: Baseline, Weeks 4, 8, 12 and 16
measure: Summary of Plasma PF-04634817 Pharmacokinetic (PK) Concentrations at Day 1 and Weeks 1, 4, 8 and 12
timeFrame: 1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12
Other outcomes:
measure: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 1, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 1, 4, 8, 12 and 16
measure: Change From Baseline in Pulse Rate at Weeks 1, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 1, 4, 8, 12 and 16
measure: Change From Baseline in Body Weight at Weeks 1, 4, 8, 12 and 16
timeFrame: Baseline, Weeks 1, 4, 8, 12 and 16
measure: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
timeFrame: Baseline up to Week 16 (follow-up visit)
measure: Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
timeFrame: Baseline, Weeks 1, 4 and 12
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 28 days after last study drug administration
measure: Number of Participants With Increased Fasting Blood Glucose
timeFrame: Baseline up to Week 16 (follow-up visit)
Locations:
city: Little Rock
country: United States
facility: Medical Investigations, Inc.
state: Arkansas
city: Azusa
country: United States
facility: North America Research Institute
state: California
city: Chula Vista
country: United States
facility: California Institute of Renal Research
state: California
city: Covina
country: United States
facility: California Kidney Specialists
state: California
city: Huntington Beach
country: United States
facility: Diabetes/Lipid Management and Research Center
state: California
city: Los Angeles
country: United States
facility: Tower Nephrology Medical Group
state: California
city: Los Gatos
country: United States
facility: Richard S. Cherlin, MD
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: Palm Springs
country: United States
facility: Desert Oasis Healthcare Medical Group
state: California
city: Salinas
country: United States
facility: Central Coast Nephrology
state: California
city: San Dimas
country: United States
facility: California Kidney Specialists
state: California
city: Aurora
country: United States
facility: University of Colorado Denver/University of Colorado Hospital
state: Colorado
city: Clearwater
country: United States
facility: Gulf Coast Endocrine and Diabetes Center
state: Florida
city: Doral
country: United States
facility: Continental Research Corp.
state: Florida
city: Hialeah
country: United States
facility: Premier Research Associate, Inc.
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center, Inc
state: Florida
city: Miami
country: United States
facility: Prestige Clinical Research Center
state: Florida
city: Miami
country: United States
facility: Elite Clinical Research
state: Florida
city: Miami
country: United States
facility: Nephrology Associates of South Miami
state: Florida
city: Miami
country: United States
facility: Tellus Clinical Research, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Diabetes Care Center
state: Florida
city: New Port Richey
country: United States
facility: Gulf Coast Kidney Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Clinical Research, Inc.
state: Florida
city: Champaign
country: United States
facility: Christie Clinic, LLC
state: Illinois
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Metairie
country: United States
facility: Crescent City Clinical Research Center
state: Louisiana
city: New Orleans
country: United States
facility: CTRC, Interim LSU Public Hospital
state: Louisiana
city: New Orleans
country: United States
facility: Pharmacy Department, Interim LSU Public Hospital
state: Louisiana
city: Bethesda
country: United States
facility: A. Kaldun Nossuli MD Research
state: Maryland
city: Springfield
country: United States
facility: Western New England Renal and Transplant Associates, PC
state: Massachusetts
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Flint
country: United States
facility: Apex Medical Research, MI, Inc.
state: Michigan
city: Troy
country: United States
facility: Troy Internal Medicine, PC
state: Michigan
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC
state: Missouri
city: Kansas City
country: United States
facility: VA Medical Center
state: Missouri
city: Omaha
country: United States
facility: Creighton Diabetes Center
state: Nebraska
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: Mineola
country: United States
facility: Winthrop University Hospital, Division of Nephrology and Hypertension
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital, Pharmacy Department
state: New York
city: Northport
country: United States
facility: Northport VA Medical Sciences Center
state: New York
city: Asheville
country: United States
facility: Mountain Kidney and Hypertension Associates, PA
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University Nephrology Research
state: North Carolina
city: Morehead City
country: United States
facility: Down East Medical Associates, P.A.
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare/Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Brookview Hills Research Associates, LLC
state: North Carolina
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: BRAHN-Hypertension and Nephrology, Inc
state: Rhode Island
city: Orangeburg
country: United States
facility: South Carolina Nephrology and Hypertension Center, Inc.
state: South Carolina
city: Memphis
country: United States
facility: The Endocrine Clinic, PC
state: Tennessee
city: Nashville
country: United States
facility: Nephrology Associates, P.C.
state: Tennessee
city: Greenville
country: United States
facility: Independent Clinical Research
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Houston
country: United States
facility: Southwest Nephrology Associates, LLP
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research LTD
state: Texas
city: Richmond
country: United States
facility: Southwest Nephrology Associates, LLP
state: Texas
city: San Antonio
country: United States
facility: Clinical Advancement Center, PLLC
state: Texas
city: San Antonio
country: United States
facility: Briggs Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
state: Texas
city: Sugar Land
country: United States
facility: Southwest Nephrology Associates, LLP
state: Texas
city: Saint George
country: United States
facility: Southern Utah Kidney and Hypertension
state: Utah
city: Burke
country: United States
facility: Burke Internal Medicine & Research
state: Virginia
city: Burke
country: United States
facility: Clinical Research Institute of Northern Virginia, Inc.
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center
state: Virginia
city: Milwaukee
country: United States
facility: Zablocki Veterans Affairs Medical Center
state: Wisconsin
city: Junin
country: Argentina
facility: Centro de Salud Renal Junin S.R.L.
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes S.R.L
state: Buenos Aires
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes "Juana Francisca Cabral"
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral S.R.L.
city: Tucumán
country: Argentina
facility: CETENE S.A. - Centro de Nefrologia y Dialisis
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: Department of Nephrology
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital, Department of Renal Medicine
state: New South Wales
city: Nambour
country: Australia
facility: Sunshine Coast Hospital & Health Service
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: BC Diabetes.ca
state: British Columbia
city: Courtice
country: Canada
facility: Co-Medica Research Network Inc.
state: Ontario
city: Scarborough
country: Canada
facility: OTT Healthcare Incorporated
state: Ontario
city: Toronto
country: Canada
facility: Dr. Stephen S. Chow Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Medical Centre
state: Ontario
city: Laval
country: Canada
facility: Centre de Recherche Clinique de Laval
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont-Nephrology
state: Quebec
city: Montreal
country: Canada
facility: Hopital Du Sacre-Coeur de Montreal Centre de recherche
state: Quebec
city: St-Romuald
country: Canada
facility: Pro-Recherche
state: Quebec
city: Herzberg
country: Germany
facility: Dialysezentrum Elsterland
state: Brandenburg
city: Aschaffenburg
country: Germany
facility: Studienzentrum Haematologie/Onkologie/Diabetologie
city: Berlin
country: Germany
facility: Universitatsmedizin Berlin - Charite Campus Mitte
city: Dresden
country: Germany
facility: GWT-TUD GmbH
city: Duesseldorf
country: Germany
facility: Studienzentrum Karlstrasse GmbH
city: Essen
country: Germany
facility: Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)
city: Falkensee
country: Germany
facility: Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hoyerswerda
country: Germany
facility: Nephrologisches Zentrum Hoyerswerda
city: Neuwied
country: Germany
facility: Zentrum Klinische Studien Neuwied
city: Schwabenheim
country: Germany
facility: Diabetologische Schwerpunktpraxis
city: Shatin, New Territories
country: Hong Kong
facility: Department of Medicine and Therapeutics, Prince of Wales Hospital,
state: Hong Kong SAR
city: Shatin, New Territories
country: Hong Kong
facility: Department of Medicine and Therapeutics
state: Hong Kong SAR
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Bari
country: Italy
facility: AOU Consorziale Policlinico di Bari
state: BA
city: Lido Camaiore. (Lucca)
country: Italy
facility: Ospedale Versilia
state: Lucca
city: Lido di Camaiore (LUCCA)
country: Italy
facility: *Ospedale Versilia
state: Lucca
city: Lido di Camaiore (LUCCA)
country: Italy
facility: Ospedale Versilia
state: Lucca
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena
state: MO
city: Foggia
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti di Foggia
city: Lecco
country: Italy
facility: Ospedale Alessandro Manzoni
city: Milano
country: Italy
facility: Unita Cardiometabolica e Trials Clinici
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Kubong Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
city: Taiping
country: Malaysia
facility: Hospital Taiping
state: Perak
city: Batu Caves
country: Malaysia
facility: Selayang Hospital
state: Selangor
city: Lima
country: Peru
facility: Casa de Diabetes y Nutricion
city: Lima
country: Peru
facility: Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio
city: Lima
country: Peru
facility: Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL
city: Lima
country: Peru
facility: Clinica Maison de Sante ¿ Sede este
city: Piura
country: Peru
facility: Clinica Virgen Maria Auxiliadora
city: Krakow
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z.o.o.
state: Malopolskie
city: Golub-Dobrzyn
country: Poland
facility: Stacja Dializ
city: Krakow
country: Poland
facility: LANDA Specjalistyczne Gabinety Lekarskie
city: Krakow
country: Poland
facility: SCM Sp. z.o.o
city: Lodz
country: Poland
facility: Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek
city: Lodz
country: Poland
facility: NZOZ TRI-medica
city: Warszawa
country: Poland
facility: CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii
city: Zamosc
country: Poland
facility: KO-MED, Central Kliniczne Sp. z.o.o
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine - CAIMED Center
city: Rio Piedras
country: Puerto Rico
facility: Medical Sciences Campus University of Puerto Rico
city: Oradea
country: Romania
facility: Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea
state: jud. Bihor
city: Bucuresti
country: Romania
facility: Institutul National de Diabet, Nutritie si Boli Metabolice
city: Ploiesti
country: Romania
facility: Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Barcelona
country: Spain
facility: Parc de Salut Mar. Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
city: Valencia
country: Spain
facility: Hospital Universitario Dr Peset
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: