MedTrace Logo

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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2015-10-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Diabetic Nephropathy

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • United States
  • Argentina
  • Australia
  • Canada
  • Germany
  • Hong Kong
  • Italy
  • Malaysia
  • Peru
  • Poland
  • Puerto Rico
  • Romania
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01712061 on ClinicalTrials.gov