Atacicept in Subjects With IgA Nephropathy (ORIGIN)
Atacicept in Subjects With IgA Nephropathy (ORIGIN)
Brief Summary:
The objective of the study is to evaluate the effect of atacicept compared to placebo on change in proteinuria in adult subjects with IGAN.
Detailed Description:
The study will assess multiple doses of atacicept vs. placebo on impact of renal function as measured by proteinuria. Safety, eGFR, serum immunoglobulins and gd-IgA1 will also be clinically assessed. The clinical study is comprised of a 36wk double-blind treatment period, followed by a 60wk open-label treatment period and a 26wk safety follow-up period.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIb Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Atacicept in Subjects With IgA Nephropathy (IGAN)
Actual Study Start Date: May 18, 2021
Estimated Primary Completion Date: December 2022
Estimated Study Completion Date: July 2024
Arm:
- Experimental: Atacicept Dose A
- Experimental: Atacicept Dose B
- Experimental: Atacicept Dose C
- Placebo Comparator: Placebo to match Atacicept
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 105 |
| Actual Study start date | 18 May 2021 |
| Estimated Study Completion Date | 01 July 2024 |