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Diabetic NephropathyPhase 2NCT01712061

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 study testing PF-04634817 in people with Diabetic Nephropathy, run by Pfizer at 142 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Nephropathy
What is being tested?
PF-04634817
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
142 sitesin 14 countries
Study dates
Dec 2012to Sep 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

142 sites in 14 countries.

142 sites in 14 countries

United States65 sites

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • Mountain Kidney and Hypertension Associates, PA

    Asheville, North Carolina, 28801

  • University of Colorado Denver/University of Colorado Hospital

    Aurora, Colorado, 80045

  • North America Research Institute

    Azusa, California, 91702

  • A. Kaldun Nossuli MD Research

    Bethesda, Maryland, 20814

  • Burke Internal Medicine & Research

    Burke, Virginia, 22015

  • Clinical Research Institute of Northern Virginia, Inc.

    Burke, Virginia, 22015

  • Christie Clinic, LLC

    Champaign, Illinois, 61820

  • California Institute of Renal Research

    Chula Vista, California, 91910

  • Gulf Coast Endocrine and Diabetes Center

    Clearwater, Florida, 33756

  • California Kidney Specialists

    Covina, California, 91723

  • Continental Research Corp.

    Doral, Florida, 33126

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Apex Medical Research, MI, Inc.

    Flint, Michigan, 48504

  • East Carolina University Nephrology Research

    Greenville, North Carolina, 27834

  • Independent Clinical Research

    Greenville, Texas, 75402

  • Premier Research Associate, Inc.

    Hialeah, Florida, 33012

  • Clinical Trial Network

    Houston, Texas, 77074

  • Southwest Nephrology Associates, LLP

    Houston, Texas, 77074

  • Southwest Houston Research LTD

    Houston, Texas, 77099

  • Diabetes/Lipid Management and Research Center

    Huntington Beach, California, 92648

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • VA Medical Center

    Kansas City, Missouri, 64128

  • Medical Investigations, Inc.

    Little Rock, Arkansas, 72205

  • Tower Nephrology Medical Group

    Los Angeles, California, 90048

  • Richard S. Cherlin, MD

    Los Gatos, California, 95032

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • The Endocrine Clinic, PC

    Memphis, Tennessee, 38119

  • Crescent City Clinical Research Center

    Metairie, Louisiana, 70006

  • Prestige Clinical Research Center

    Miami, Florida, 33133

  • Elite Clinical Research

    Miami, Florida, 33144

  • Nephrology Associates of South Miami

    Miami, Florida, 33173

  • Tellus Clinical Research, Inc.

    Miami, Florida, 33173

  • Ocean Blue Medical Research Center, Inc

    Miami Springs, Florida, 33166

  • Zablocki Veterans Affairs Medical Center

    Milwaukee, Wisconsin, 53295

  • Winthrop University Hospital, Division of Nephrology and Hypertension

    Mineola, New York, 11501

  • Winthrop University Hospital, Pharmacy Department

    Mineola, New York, 11501

  • Down East Medical Associates, P.A.

    Morehead City, North Carolina, 28557

  • Nephrology Associates, P.C.

    Nashville, Tennessee, 37205

  • CTRC, Interim LSU Public Hospital

    New Orleans, Louisiana, 70112

  • Pharmacy Department, Interim LSU Public Hospital

    New Orleans, Louisiana, 70112

  • Diabetes Care Center

    New Port Richey, Florida, 34652

  • Gulf Coast Kidney Center

    New Port Richey, Florida, 34652

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Providence Clinical Research

    North Hollywood, California, 91606

  • Northport VA Medical Sciences Center

    Northport, New York, 11768

  • Creighton Diabetes Center

    Omaha, Nebraska, 68131

  • South Carolina Nephrology and Hypertension Center, Inc.

    Orangeburg, South Carolina, 29118

  • Four Rivers Clinical Research, Inc.

    Paducah, Kentucky, 42003

  • Desert Oasis Healthcare Medical Group

    Palm Springs, California, 92262

  • Pines Clinical Research, Inc.

    Pembroke Pines, Florida, 33028

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • BRAHN-Hypertension and Nephrology, Inc

    Providence, Rhode Island, 02904

  • Southwest Nephrology Associates, LLP

    Richmond, Texas, 77469

  • Central Coast Nephrology

    Salinas, California, 93901

  • Clinical Advancement Center, PLLC

    San Antonio, Texas, 78215

  • Briggs Clinical Research, LLC

    San Antonio, Texas, 78224

  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.

    San Antonio, Texas, 78229

  • California Kidney Specialists

    San Dimas, California, 91773

  • Western New England Renal and Transplant Associates, PC

    Springfield, Massachusetts, 01107

  • Southern Utah Kidney and Hypertension

    St. George, Utah, 84770

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Southwest Nephrology Associates, LLP

    Sugar Land, Texas, 77478

  • Troy Internal Medicine, PC

    Troy, Michigan, 48098

  • Brookview Hills Research Associates, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany11 sites

  • Studienzentrum Haematologie/Onkologie/Diabetologie

    Aschaffenburg, 63739

  • Universitatsmedizin Berlin - Charite Campus Mitte

    Berlin, 10117

  • GWT-TUD GmbH

    Dresden, 01307

  • Studienzentrum Karlstrasse GmbH

    Düsseldorf, 40210

  • Profil Institut fuer Stoffwechselforschung GmbH (branch: Diabetes Praxis Essen)

    Essen, 45136

  • Diabetes Schwerpunktpraxis / Zentrum fur Klinische Studien

    Falkensee, 14612

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Dialysezentrum Elsterland

    Herzberg, Brandenburg, 04916

  • Nephrologisches Zentrum Hoyerswerda

    Hoyerswerda, 02977

  • Zentrum Klinische Studien Neuwied

    Neuwied, D-56564

  • Diabetologische Schwerpunktpraxis

    Schwabenheim, 55270

Other trials in Germany

Canada10 sites

  • Co-Medica Research Network Inc.

    Courtice, Ontario, L1E 3C3

  • Centre de Recherche Clinique de Laval

    Laval, Quebec, H7T 2P5

  • Hopital Maisonneuve-Rosemont-Nephrology

    Montreal, Quebec, H1T 2M4

  • Hopital Du Sacre-Coeur de Montreal Centre de recherche

    Montreal, Quebec, H4J 1C5

  • Pro-Recherche

    Saint Romuald, Quebec, G6W 5M6

  • OTT Healthcare Incorporated

    Scarborough Village, Ontario, M1H 3G4

  • Dr. Stephen S. Chow Medicine Professional Corporation

    Toronto, Ontario, M4C 5T2

  • Toronto East General Medical Centre

    Toronto, Ontario, M4C 5T2

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1L8

  • BC Diabetes.ca

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy9 sites

  • AOU Consorziale Policlinico di Bari

    Bari, BA, 70124

  • Azienda Ospedaliera Ospedali Riuniti di Foggia

    Foggia, 71100

  • Ospedale Alessandro Manzoni

    Lecco, Italy, 23900

  • Ospedale Versilia

    Lido Camaiore. (Lucca), Lucca, 55041

  • *Ospedale Versilia

    Lido Di Camaiore (lucca), Lucca, 55043

  • Ospedale Versilia

    Lido Di Camaiore (lucca), Lucca, 55043

  • Unita Cardiometabolica e Trials Clinici

    Milan, 20132

  • A.O.U. Policlinico di Modena

    Modena, MO, 41124

  • Fondazione Salvatore Maugeri Clinica del Lavoro e della Riabilitazione IRCCS

    Pavia, 27100

Other trials in Italy

Poland8 sites

  • Stacja Dializ

    Golub-Dobrzyń, 87-400

  • Krakowskie Centrum Medyczne Sp. z.o.o.

    Krakow, Lesser Poland Voivodeship, 31-501

  • LANDA Specjalistyczne Gabinety Lekarskie

    Krakow, 30-015

  • SCM Sp. z.o.o

    Krakow, 31-559

  • Klinika Nefrologii, Hipertensjologii i Transplantologii Nerek

    Lodz, 92-013

  • NZOZ TRI-medica

    Lodz, 93-338

  • CSK MSW w Warszawie Klinika Chorob Wewnetrznych Endokrynologii i Diabetologii

    Warsaw, 02-507

  • KO-MED, Central Kliniczne Sp. z.o.o

    Zamość, 22-400

Other trials in Poland

Australia7 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Sunshine Coast Hospital & Health Service

    Nambour, Queensland, 4560

  • Department of Nephrology

    New Lambton, New South Wales, 2305

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Westmead Hospital, Department of Renal Medicine

    Westmead, New South Wales, 2145

Other trials in Australia

Argentina6 sites

  • Instituto de Cardiologia de Corrientes "Juana Francisca Cabral"

    Corrientes, W3400AMZ

  • Centro de Salud Renal Junin S.R.L.

    Junín, Buenos Aires, 6000

  • Centro de Investigaciones Medicas - Clinica de Fracturas y Ortopedia

    Mar del Plata, Buenos Aires, B7600DHK

  • Instituto de Investigaciones Clinicas Quilmes S.R.L

    Quilmes, Buenos Aires, B1878GEG

  • CETENE S.A. - Centro de Nefrologia y Dialisis

    San Miguel de Tucumán, T4000IIO

  • Centro de Investigaciones Clinicas del Litoral S.R.L.

    Santa Fe, 3000

Other trials in Argentina

Spain6 sites

  • Parc de Salut Mar. Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Universitario Dr Peset

    Valencia, 46017

Other trials in Spain

Peru5 sites

  • Casa de Diabetes y Nutricion

    Lima, Lima Province, 17

  • Consultorio de Endocrinologia - LM Servicios Medicos y Endocrinologicos EIRL

    Lima, Lima Province, 27

  • Centro de Investigacion y Atencion Cardiovascular S.A.C. - Clinica Novocardio

    Lima, 27

  • Clinica Maison de Sante ¿ Sede este

    Lima, LIMA 33

  • Clinica Virgen Maria Auxiliadora

    Piura, 073

Other trials in Peru

Romania4 sites

  • Institutul National de Diabet, Nutritie si Boli Metabolice

    Bucharest, 020475

  • Spital Clinic Municipal "Dr. Gavril Curteanu" Oradea

    Oradea, Jud. Bihor, 410469

  • Elit Medical SRL, Diabet Zaharat Nutritie si Boli Metabolice

    Ploieşti, 100018

  • Spitalul Clinic Judetean de Urgenta Timisoara

    Timișoara, 300736

Other trials in Romania

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong

  • Department of Medicine and Therapeutics, Prince of Wales Hospital,

    Shatin, New Territories, Hong Kong SAR

  • Department of Medicine and Therapeutics

    Shatin, New Territories, Hong Kong SAR

Other trials in Hong Kong

Malaysia3 sites

  • Selayang Hospital

    Batu Caves, Selangor, 68100

  • Hospital Universiti Sains Malaysia

    Kubong Kerian, Kelantan, 16150

  • Hospital Taiping

    Taiping, Perak, 34000

Other trials in Malaysia

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 110-744

  • Yonsei University College of Medicine, Severance Hospital

    Seoul, 120-752

  • Chung-Ang University Hospital

    Seoul, 156-755

Other trials in South Korea

Puerto Rico2 sites

  • Ponce School of Medicine - CAIMED Center

    Ponce, 00716

  • Medical Sciences Campus University of Puerto Rico

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

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

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.

Being tested
PF-04634817, Placebo
Keywords
Diabetic nephropathy, type 2 diabetes, albuminuria, chemokine antagonist
Medical subject headings
Diabetic Nephropathies, Diabetes Mellitus, Type 2, Albuminuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-04634817Drug

    Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

  • PlaceboDrug

    Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

Study groups in NCT01712061
Study groupRoleWhat they receive
Arm 1 PF-04634817Active comparatorNot described
Receives: Drug: PF-04634817
Arm 2 PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 12

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, Weeks 4, 8 and 16

  2. 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.

    Measured: Baseline, Weeks 4, 8, 12 and 16

  3. 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

    Measured: Baseline, Week 1, 4, 8, 12 and 16

  4. 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.

    Measured: Baseline, Week 12, and Week 16

  5. 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.

    Measured: Baseline, Week 1, 4, 8, 12 and 16

  6. 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.

    Measured: Baseline, Week 12, and Week 16

  7. 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.

    Measured: Baseline, Weeks 4, 8, 12 and 16

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

    Measured: 1, 2, 4 hours post-dose on Day 1; 2 hours post-dose on Weeks 1, 4, 8 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01712061
Sponsor's protocol ID
B1261007
Other IDs
2012-003332-23
Status last verified
Sep 2015
First submitted
19 Oct 2012
Last updated
21 Oct 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-04634817 in people with Diabetic Nephropathy, run by Pfizer at 142 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Germany, Canada, Italy, Poland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Reduction From Baseline in Urinary Albumin to Creatinine Ratio (UACR) at Week 12 (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01712061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.

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