Clinical Trial: Clinical Trial to Evaluate Safety and Efficacy of CCX168 in ANCA-Associated Vasculitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose Assessment Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasc
Brief Summary:
The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Funding Source - FDA OOPD
Detailed Summary: Complement 5a and its receptor C5aR (CD88) is involved in the pathogenesis of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. This is a randomized, double-blind, placebo-controlled Phase 2 study to evaluate the safety and efficacy of the C5aR inhibitor CCX168 in subjects with ANCA-associated vasculitis. The aim of this trial is to test the safety and efficacy of two dose regimens of the complement C5a receptor CCX168 in patients with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV).
Sponsor: ChemoCentryx
Current Primary Outcome: BVAS [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- eGFR [ Time Frame: 12 weeks ]
- Hematuria [ Time Frame: 12 weeks ]
- Albuminuria [ Time Frame: 12 weeks ]
- Urinary monocyte chemoattractant protein-1 (MCP-1) [ Time Frame: 12 weeks ]
Original Secondary Outcome:
- eGFR [ Time Frame: 12 weeks ]
- Hematuria [ Time Frame: 12 weeks ]
- Albuminuria [ Time Frame: 12 weeks ]
- Urinary MCP-1 [ Time Frame: 12 weeks ]
Information By: ChemoCentryx
Dates:
Date Received: August 19, 2014
Date Started: September 2014
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016