At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 226 enrolled
Drug / intervention
PF-04634817 +1 moredrug
Likely dose
PF-04634817 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating PF-04634817 and Placebo for Diabetic Nephropathy. Completed, enrolled 226 participants across 142 sites in 14 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Nephropathy
CountriesArgentina, Australia, Canada, Germany, Hong Kong, Italy, Malaysia, Peru, Poland, Puerto Rico, Romania, South Korea, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartDec 2012
Primary CompletionSep 2014
TodayJul 2026
First PostedOct 23, 2012
Enrollment StartDec 1, 2012
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.7 years ago
Interventions
PF-04634817drug
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
Placebodrug
Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function