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 August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01712061
First received: October 19, 2012
Last updated: August 12, 2014
Last verified: August 2014

October 19, 2012
August 12, 2014
December 2012
September 2014   (final data collection date for primary outcome measure)
Urinary albumin:creatinine ratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01712061 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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, 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetic Nephropathy
  • 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
  • Active Comparator: Arm 1 PF-04634817
    Intervention: Drug: PF-04634817
  • Placebo Comparator: Arm 2 Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
176
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Argentina,   Australia,   Canada,   Germany,   Hong Kong,   Italy,   Korea, Republic of,   Malaysia,   Peru,   Poland,   Puerto Rico,   Romania,   Spain
 
NCT01712061
B1261007
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

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