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.
Verified April 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01712061
First received: October 19, 2012
Last updated: April 13, 2014
Last verified: April 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712061

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

  Show 150 Study Locations
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: April 13, 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 April 23, 2014