A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria
The purpose of this study is to evaluate the effect of treatment with CCX140-B on urinary albumin excretion in subjects with type 2 diabetes mellitus and albuminuria, as well as to study the safety and efficacy of the medication in this patient population.
Type 2 Diabetes Mellitus
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Effect of CCX140-B on Albuminuria in Subjects With Type 2 Diabetes Mellitus|
- Change from baseline in 24-hour urinary albumin excretion [ Time Frame: 84 days ] [ Designated as safety issue: No ]The primary efficacy objective of this study is to evaluate the effect of CCX140-B treatment on urinary albumin excretion by measuring change from baseline in 24-hour urinary albumin excretion.
- Subject incidence of adverse events [ Time Frame: 84 days ] [ Designated as safety issue: Yes ]The primary safety objective of this study is to evaluate the safety and tolerability of CCX140-B in subjects with type 2 diabetes mellitus (T2DM) with albuminuria.
- Change from baseline in hemoglobin A1c [ Time Frame: 84 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||September 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo (Group A)||
Placebo capsules once daily
Experimental: Active study medication (Group B)
CCX140-B capsules once daily (Group B)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01440257
|Centre for Human Drug Research|
|Study Director:||Pirow Bekker, MD, PhD||ChemoCentryx, Inc.|