A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01712061
First received: October 19, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Evaluate The Efficacy And Safety Of Once-Daily Administration Of A Chemokine CCR2/5 Receptor Antagonist (PF-04634817) In Adults With Type 2 Diabetes And Overt Nephropathy

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

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

Estimated Enrollment: 176
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 PF-04634817 Drug: PF-04634817
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Placebo Comparator: Arm 2 Placebo Drug: Placebo
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2.
  • Evidence of persistent, overt albuminuria; defined as a UACR >=300 mg/g (>=33.9 mg/mmol) or UPCR >=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
  • Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.

Exclusion Criteria:

  • Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
  • Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712061

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Hide Study Locations
Locations
United States, Arkansas
Pfizer Investigational Site Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site Recruiting
Azusa, California, United States, 91702
Pfizer Investigational Site Recruiting
Chula Vista, California, United States, 91910
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Huntington Beach, California, United States, 92648
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Laguna Niguel, California, United States, 92667
Pfizer Investigational Site Recruiting
Los Angeles, California, United States, 90048
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Los Gatos, California, United States, 95032
Pfizer Investigational Site Recruiting
North Hollywood, California, United States, 91606
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Orange, California, United States, 92868
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Palm Springs, California, United States, 92262
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Salinas, California, United States, 93901
United States, Colorado
Pfizer Investigational Site Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Pfizer Investigational Site Recruiting
Groton, Connecticut, United States, 06340
United States, Florida
Pfizer Investigational Site Terminated
Clearwater, Florida, United States, 33756
Pfizer Investigational Site Recruiting
Hialeah, Florida, United States, 33012
Pfizer Investigational Site Not yet recruiting
Lynn Haven, Florida, United States, 32444
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33155
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Miami, Florida, United States, 33133
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33134
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33173
Pfizer Investigational Site Recruiting
Miami, Florida, United States, 33144
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Miami Springs, Florida, United States, 33166
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New Port Richey, Florida, United States, 34652
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Pembroke Pines, Florida, United States, 33028
United States, Georgia
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Atlanta, Georgia, United States, 30342
United States, Illinois
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Burr Ridge, Illinois, United States, 60527
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Champaign, Illinois, United States, 61820
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Champaign, Illinois, United States, 61822
United States, Indiana
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Indianapolis, Indiana, United States, 46214
United States, Kentucky
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Paducah, Kentucky, United States, 42003
United States, Louisiana
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Metairie, Louisiana, United States, 70006
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New Orleans, Louisiana, United States, 70112
United States, Maryland
Pfizer Investigational Site Terminated
Bethesda, Maryland, United States, 20814
United States, Massachusetts
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Springfield, Massachusetts, United States, 01107
United States, Michigan
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Flint, Michigan, United States, 48504
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Flint, Michigan, United States, 48503
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Troy, Michigan, United States, 48098
United States, Missouri
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Kansas City, Missouri, United States, 64111
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Kansas City, Missouri, United States, 64128
United States, Nebraska
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Omaha, Nebraska, United States, 68131
United States, New Mexico
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Albuquerque, New Mexico, United States, 87109
United States, New York
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Mineola, New York, United States, 11501
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Northport, New York, United States, 11768
United States, North Carolina
Pfizer Investigational Site Terminated
Asheville, North Carolina, United States, 28801
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Greenville, North Carolina, United States, 27834
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Morehead City, North Carolina, United States, 28557
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Statesville, North Carolina, United States, 28625
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Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
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Doylestown, Pennsylvania, United States, 18901
United States, Rhode Island
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Providence, Rhode Island, United States, 02903
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Providence, Rhode Island, United States, 02904
United States, South Carolina
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Orangeburg, South Carolina, United States, 29118
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
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Chattanooga, Tennessee, United States, 37408
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Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37205
United States, Texas
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Greenville, Texas, United States, 75402
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Houston, Texas, United States, 77074
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Houston, Texas, United States, 77099
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Richmond, Texas, United States, 77469
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78215
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San Antonio, Texas, United States, 78224
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Sugar Land, Texas, United States, 77478
United States, Utah
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Saint George, Utah, United States, 84770
United States, Virginia
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Burke, Virginia, United States, 22015
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Burke, Virginia, United States, 22015-4202
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Manassas, Virginia, United States, 20110
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53295
Argentina
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Junin, Buenos Aires, Argentina, 6000
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Mar del Plata, Buenos Aires, Argentina, B7600DHK
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Quilmes, Buenos Aires, Argentina, B1878GEG
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Cordoba, Argentina, X5002HWE
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Corrientes, Argentina, W3400AMZ
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Santa Fe, Argentina, 3000
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Tucumán, Argentina, T4000IIO
Australia, New South Wales
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Liverpool, New South Wales, Australia, 2170
Pfizer Investigational Site Completed
New Lambton, New South Wales, Australia, 2305
Pfizer Investigational Site Terminated
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Pfizer Investigational Site Completed
Nambour, Queensland, Australia, 4560
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Clayton, Victoria, Australia, 3168
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Parkville, Victoria, Australia, 3050
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
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Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
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Courtice, Ontario, Canada, L1E 3C3
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Scarborough, Ontario, Canada, M1H 3G4
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Toronto, Ontario, Canada, M4C 5T2
Canada, Quebec
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Laval, Quebec, Canada, H7T 2P5
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H4J 1C5
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Montreal, Quebec, Canada, H1T 2M4
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St-Romuald, Quebec, Canada, G6W 5M6
Germany
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Herzberg, Brandenburg, Germany, 04916
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Hoyerswerda, Saxony, Germany, 02977
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Aschaffenburg, Germany, 63739
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Berlin, Germany, 10117
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Dresden, Germany, 01307
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Duesseldorf, Germany, 40210
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Essen, Germany, 45136
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Falkensee, Germany, 14612
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Hannover, Germany, 30625
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Neuwied, Germany, D-56564
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Schwabenheim, Germany, 55270
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Speyer, Germany, 67346
Hong Kong
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Shatin, New Territories, Hong Kong SAR, Hong Kong
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Hong Kong, Hong Kong
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Shatin, Hong Kong
Italy
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Bari, BA, Italy, 70124
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Milano, MI, Italy, 20157
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Milano, MI, Italy, 20132
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Modena, MO, Italy, 41124
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Foggia, Italy, 71100
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Lecco, Italy, 23900
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Lido Camaiore. (Lucca), Italy, 55041
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Milano, Italy, 20132
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Pavia, Italy, 27100
Korea, Republic of
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Seoul, Korea, Republic of, 156-755
Pfizer Investigational Site Completed
Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 120-752
Pfizer Investigational Site Active, not recruiting
Seoul, Korea, Republic of
Malaysia
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Kubong Kerian, Kelantan, Malaysia, 16150
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Taiping, Perak, Malaysia, 34000
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Batu Caves, Selangor, Malaysia, 68100
Peru
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Lima, Peru, 17
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Lima, Peru, 27
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Lima, Peru, LIMA 33
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Lima, Peru, 27
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Piura, Peru, 073
Poland
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Lodz, Lodzkie, Poland, 93-338
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Krakow, Malopolska, Poland, 30-015
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Krakow, Malopolskie, Poland, 31-501
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Krakow, Malopolskie, Poland, V
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Zabrze, Slaskie, Poland, 41-800
Pfizer Investigational Site Recruiting
Golub-Dobrzyn, Poland, 87-400
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Krakow, Poland, 31-559
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Lodz, Poland, 93-428
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Lodz, Poland, 92-013
Pfizer Investigational Site Not yet recruiting
Warszawa, Poland, 04-749
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Warszawa, Poland, 02-507
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Zamosc, Poland, 22-400
Puerto Rico
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Ponce, Puerto Rico, 00716
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Rio Piedras, Puerto Rico, 00935
Romania
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Indianapolis, IN, Romania, 46214
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Oradea, jud. Bihor, Romania, 410469
Pfizer Investigational Site Recruiting
Bucuresti, Romania, 020475
Pfizer Investigational Site Recruiting
Ploiesti, Romania, 100018
Pfizer Investigational Site Recruiting
Timisoara, Romania, 300736
Spain
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Majadahonda, Madrid, Spain, 28222
Pfizer Investigational Site Recruiting
Madrid, Majadahonda, Spain, 28222
Pfizer Investigational Site Recruiting
Barcelona, Spain, 08003
Pfizer Investigational Site Recruiting
Barcelona, Spain, 08035
Pfizer Investigational Site Recruiting
Barcelona, Spain, 08907
Pfizer Investigational Site Not yet recruiting
Barcelona, Spain, 08036
Pfizer Investigational Site Not yet recruiting
Galdacano, Spain, 48960
Pfizer Investigational Site Recruiting
Girona, Spain, 17007
Pfizer Investigational Site Recruiting
Valencia, Spain, 46017
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01712061     History of Changes
Other Study ID Numbers: B1261007
Study First Received: October 19, 2012
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 20, 2014