NCT01712061

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2012-10-23
• Last updated: 2015-10-21
• Results posted: 2015-10-21

Locations

142 sites across 14 countries: United States, Argentina, Australia, Canada, Germany, Hong Kong, Italy, Malaysia, Peru, Poland, Puerto Rico, Romania, South Korea, Spain