Efficacy and Safety of Atacicept in IgA Nephropathy

• Status: Terminated
• Trial end date: 2020-02-07
• Target enrollment: 0
• Participant gender: All

Summary

This main purpose of this study was to evaluate the safety, tolerability, dose response and efficacy of Atacicept in participants with IgA nephropathy and persistent proteinuria. The study hypothesis was that treatment with Atacicept would reduce proteinuria compared to placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany

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), or untreated latent TB infection

• History of or positive HIV and/or positive for hepatitis B or Hepatitis C at screening

• History of malignancy

• Nursing or pregnancy

• Any condition, including any uncontrolled disease state other than IgA nephropathy