NCT01447147

A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX140-B in Diabetic Nephropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B in subjects with diabetic nephropathy.

Detailed description

The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with diabetic nephropathy based on subject incidence of adverse events. The secondary objectives of this study include evaluation of the effect of CCX140-B on several measures of effectiveness commonly used in the evaluation of diabetes and renal medications. Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

• Diabetic Nephropathy
• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Placebo	Placebo capsules once daily
DRUG	CCX140-B	CCX140-B capsules once daily (Group B)
DRUG	CCX140-B	CCX140-B capsules once daily (Group C)

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-08-01
• Completion: 2014-12-01
• First posted: 2011-10-06
• Last updated: 2025-02-27

Locations

83 sites across 6 countries: Belgium, Czechia, Germany, Hungary, Poland, United Kingdom