Clinical Trial: Efficacy and Safety of Atacicept in IgA Nephropathy
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
Brief Summary: This study will evaluate the safety, tolerability, dose response and efficacy of atacicept in patients with IgA nephropathy and persistent proteinuria. The study hypothesis is that treatment with atacicept will reduce proteinuria compared to placebo.
Detailed Summary:
Sponsor: EMD Serono Research & Development Institute, Inc.
Current Primary Outcome:
- Part A: Proportion of subjects with Adverse events (AE), AEs of special interest (AESIs), serious AEs, AEs leading to discontinuation, and AEs leading to death [ Time Frame: Up to 48 weeks ]
- Part B: Percent change from baseline in proteinuria at Week 48 [ Time Frame: Baseline and Week 48 ]
Original Primary Outcome: Percent change from baseline in proteinuria at Week 48 [ Time Frame: Week 48 ]
Current Secondary Outcome:
- Part A: Serum atacicept concentrations [ Time Frame: Baseline, up to 96 weeks ]
- Part A: Change from baseline levels in serum immunoglobulin (Ig) classes (IgG, IgA, and IgM) [ Time Frame: Baseline, up to 96 weeks ]
- Part A: Change from baseline in serum Galactose Deficient-IgA1 (Gd-IgA1) levels [ Time Frame: Baseline, up to 96 weeks ]
- Part A: Change from baseline in serum complement C3 and C4 levels [ Time Frame: Baseline, up to 96 weeks ]
- Part A: Change from baseline in immune cell subsets by flow cytometry analysis [ Time Frame: Baseline, up to 96 weeks ]
- Part A: Change in urine immuno-electrophoresis pattern [ Time Frame: Baseline, up to 96 weeks ]
- Part A: Proportion of subjects positive for Anti-drug antibody assessment [ Time Frame: Up to 96 weeks ]
- Part A: Proportion of subjects with AEs, AESIs, serious AEs, AEs leading to discontinuation, and AEs leading to death [ Time Frame: up to 96 weeks ]
- Part A: Proportion of subjects with abnormalities in laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Up to 96 weeks ]
- Part B: Proportion of subjects achieving reduction in proteinuria from Baseline and with stable renal function [ Time Frame: Baseline, Week 48 ]
- Part B: Change from Baseline in Renal Function [ Time Frame: Baseline, Week 156 ]
- Part B: Serum atacicept concentrations [ Time Frame: Baseline, up to 180 weeks ]
- Part B: Change from baseline levels in serum immunoglobulin (Ig) classes (IgG, IgA, and IgM) [ Time Frame: Baseline, up to 180 weeks ]
- Part B: Change from baseline in serum Galactose Deficient-IgA1 (Gd-IgA1) levels [ Time Frame: Baseline, up to 180 weeks ]
- Part B: Change from baseline in serum complement C3 and C4 levels [ Time Frame: Baseline, up to 180 weeks ]
- Part B: Change from baseline in immune cell subsets by flow cytometry analysis [ Time Frame: Baseline, up to 180 weeks ]
- Part B: Change in urine immuno-electrophoresis pattern [ Time Frame: Baseline, up to 180 weeks ]
- Part B: Proportion of subjects positive for Anti-drug antibody assessment [ Time Frame: Up to 180 weeks ]
- Part B: Proportion of subjects with AEs, AESIs, AEs leading to discontinuation, SAEs, AEs leading to death [ Time Frame: Up to 180 weeks ]
- Part B: Proportion of subjects with abnormalities in laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Up to 180 weeks ]
Original Secondary Outcome:
- Proportion of subjects achieving reduction in proteinuria from Baseline and with stable renal function [ Time Frame: Baseline, Week 48 ]
- Change from Baseline in Renal Function [ Time Frame: Baseline, Week 156 ]
- Proportion of subjects with Adverse event (AE)s, AEs of special interest, serious AEs, AEs leading to discontinuation, and AEs leading to death [ Time Frame: up to 180 weeks ]
Information By: EMD Serono
Dates:
Date Received: June 16, 2016
Date Started: January 31, 2017
Date Completion: October 9, 2019
Last Updated: March 14, 2017
Last Verified: March 2017
