A Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With ANCA-Associated Renal Vasculitis
The aim of this trial is to optimize the treatment to induce remission for patients with non-life-threatening anti-neutrophil cytoplasmic antibody renal vasculitis (AARV) with mild-to-moderate renal involvement. The intent is to reduce the toxicity of induction therapy by reducing the overall exposure to or eliminating entirely the use of systemic corticosteroids during the induction period with an inhibitor of the complement C5a receptor plus cyclophosphamide.
|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 Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Renal Vasculitis on Background of Cyclophosphamide Treatment|
- Safety of CCX168 in subjects with AARV [ Time Frame: 169 days ] [ Designated as safety issue: Yes ]Safety assessments include adverse events, physical examination abnormalities, vital signs and clinical laboratory tests (including blood chemistry, hematology and urinalysis).
- Systemic corticosteroid use [ Time Frame: 169 days ] [ Designated as safety issue: No ]Systemic corticosteroid use based on total oral corticosteroid dose and duration of oral corticosteroid use
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
BID for 84 days
Active study medication
BID for 84 days
The primary objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with AARV on background of cyclophosphamide treatment.
The secondary objectives of this study include assessment of the feasibility of reducing or eliminating the use of corticosteroids in the treatment of subjects with ANCA-associated renal vasculitis without the need for rescue corticosteroid measures and the effect of CCX168 on several disease parameters.