Efficacy and Safety of Atacicept in IgA Nephropathy
A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
Sponsor: EMD Serono Research & Development Institute, Inc. + Merck KGaA, Darmstadt, Germany
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Adverse Event of Special Interest (AESIs), Serious TEAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death
Time frame: Baseline up to 96 weeks
Secondary Endpoints
Serum Atacicept Concentrations
Change From Baseline Levels in Serum Immunoglobulin A (IgA)
Change From Baseline Levels in Serum Iimmunoglobulin G (IgG)
Eligibility Criteria
Inclusion Criteria: * Greater than or equal to (\>=)18 years of age * Biopsy-proven Immunoglobulin (IgA) nephropathy * Urine Protein to Creatinine Ratio (UPCR) \>= 0.75 and \<= 6 milligram per milligram (mg/mg) during screening * Stable and optimal dose of Angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blockers (ARB) at least 8 weeks prior to screening Exclusion Criteria: * Concomitant significant renal disease other than IgA nephropathy * IgA nephropathy with significant glomerulosclerosis or cortical scarring * Diagnosis of Henoch-Schonlein purpura * Failure to meet estimated glomerular filtration rate (eGFR) and biopsy requirement criteria * Serum IgG below 6 grams per liter (g/L) * Use of cyclophosphamide ever or use of other immunosuppressants or systemic corticosteroids within 4 months * Active infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks * History, or current diagnosis, of active tuberculosis (TB…
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Expert commentary on why this trial matters and what to watch for.
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