A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
Novartis Pharmaceuticals
Summary
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
Description
This is a non-randomized, multicenter, open-label extension (OLE) study to Phase 3, randomized CHK02-02 (CFUB523A12301)-BEYOND clinical study, Phase 1/2 ADU-CL-19 (CFUB523A12103) clinical study, and any other Novartis-sponsored clinical study of zigakibart in IgAN.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the OLE study. 2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol. 3. Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W. Exclusion Criteria: 1. Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason. 2. Participants who at the time of first study treatment administration in the OLE are…
Interventions
- Drugzigakibart
solution for subcutaneous injection
Locations (15)
- Colorado Kidney Care NephrologyDenver, Colorado
- Nephrology Associates Of Central FLOrlando, Florida
- NY NephrologyClifton Park, New York
- Icahn School of Medicine at Mount SinaiNew York, New York
- Knoxville Kidney Center PllcBrentwood, Tennessee
- Dallas Renal GroupDallas, Texas