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

NCT01712061

Last updated date
Study Location
Medical Investigations, Inc.
Little Rock, Arkansas, 72205, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Nephropathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Diabetic NephropathyA 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
NCT01712061
  1. Little Rock, Arkansas
  2. Azusa, California
  3. Chula Vista, California
  4. Covina, California
  5. Huntington Beach, California
  6. Los Angeles, California
  7. Los Gatos, California
  8. North Hollywood, California
  9. Palm Springs, California
  10. Salinas, California
  11. San Dimas, California
  12. Aurora, Colorado
  13. Clearwater, Florida
  14. Doral, Florida
  15. Hialeah, Florida
  16. Miami Springs, Florida
  17. Miami, Florida
  18. Miami, Florida
  19. Miami, Florida
  20. Miami, Florida
  21. New Port Richey, Florida
  22. New Port Richey, Florida
  23. New Port Richey, Florida
  24. Pembroke Pines, Florida
  25. Champaign, Illinois
  26. Paducah, Kentucky
  27. Metairie, Louisiana
  28. New Orleans, Louisiana
  29. New Orleans, Louisiana
  30. Bethesda, Maryland
  31. Springfield, Massachusetts
  32. Flint, Michigan
  33. Flint, Michigan
  34. Troy, Michigan
  35. Kansas City, Missouri
  36. Kansas City, Missouri
  37. Omaha, Nebraska
  38. Albuquerque, New Mexico
  39. Mineola, New York
  40. Mineola, New York
  41. Northport, New York
  42. Asheville, North Carolina
  43. Greenville, North Carolina
  44. Morehead City, North Carolina
  45. Statesville, North Carolina
  46. Winston-Salem, North Carolina
  47. Providence, Rhode Island
  48. Providence, Rhode Island
  49. Orangeburg, South Carolina
  50. Memphis, Tennessee
  51. Nashville, Tennessee
  52. Greenville, Texas
  53. Houston, Texas
  54. Houston, Texas
  55. Houston, Texas
  56. Richmond, Texas
  57. San Antonio, Texas
  58. San Antonio, Texas
  59. San Antonio, Texas
  60. Sugar Land, Texas
  61. Saint George, Utah
  62. Burke, Virginia
  63. Burke, Virginia
  64. Manassas, Virginia
  65. Milwaukee, Wisconsin
  66. Junin, Buenos Aires
  67. Mar del Plata, Buenos Aires
  68. Quilmes, Buenos Aires
  69. Corrientes,
  70. Santa Fe,
  71. Tucumán,
  72. Liverpool, New South Wales
  73. New Lambton, New South Wales
  74. Westmead, New South Wales
  75. Nambour, Queensland
  76. Box Hill, Victoria
  77. Clayton, Victoria
  78. Parkville, Victoria
  79. Vancouver, British Columbia
  80. Vancouver, British Columbia
  81. Courtice, Ontario
  82. Scarborough, Ontario
  83. Toronto, Ontario
  84. Toronto, Ontario
  85. Laval, Quebec
  86. Montreal, Quebec
  87. Montreal, Quebec
  88. St-Romuald, Quebec
  89. Herzberg, Brandenburg
  90. Aschaffenburg,
  91. Berlin,
  92. Dresden,
  93. Duesseldorf,
  94. Essen,
  95. Falkensee,
  96. Hannover,
  97. Hoyerswerda,
  98. Neuwied,
  99. Schwabenheim,
  100. Shatin, New Territories, Hong Kong SAR
  101. Shatin, New Territories, Hong Kong SAR
  102. Hong Kong,
  103. Bari, BA
  104. Lido Camaiore. (Lucca), Lucca
  105. Lido di Camaiore (LUCCA), Lucca
  106. Lido di Camaiore (LUCCA), Lucca
  107. Modena, MO
  108. Foggia,
  109. Lecco,
  110. Milano,
  111. Pavia,
  112. Seoul,
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  124. Golub-Dobrzyn,
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  128. Lodz,
  129. Warszawa,
  130. Zamosc,
  131. Ponce,
  132. Rio Piedras,
  133. Oradea, jud. Bihor
  134. Bucuresti,
  135. Ploiesti,
  136. Timisoara,
  137. Hospitalet de Llobregat, Barcelona
  138. Majadahonda, Madrid
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  141. Girona,
  142. Valencia,
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Advanced Information
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Nephropathy
Intervention  ICMJE
  • Drug: PF-04634817
    Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
  • Drug: Placebo
    Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Study Arms  ICMJE
  • Active Comparator: Arm 1 PF-04634817
    Intervention: Drug: PF-04634817
  • Placebo Comparator: Arm 2 Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2014)
226
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2012)
176
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Canada,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Malaysia,   Peru,   Poland,   Puerto Rico,   Romania,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01712061
Other Study ID Numbers  ICMJE B1261007
2012-003332-23 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP