NCT02808429

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	Placebo	Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
DRUG	Atacicept 25 mg	Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
DRUG	Atacicept 75 mg	Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.

Timeline

• Start date: 2017-01-31
• Primary completion: 2020-02-07
• Completion: 2020-02-07
• First posted: 2016-06-21
• Last updated: 2021-02-25
• Results posted: 2021-02-25

Locations

18 sites across 3 countries: United States, Japan, United Kingdom

Regulatory

• FDA-regulated drug study