A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Signed informed consent must be obtained prior to participation in the OLE study.
• Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.
• Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.
Locations
United States
Colorado
Colorado Kidney Care Nephrology
RECRUITING
Denver
New York
NY Nephrology
RECRUITING
Clifton Park
Tennessee
Knoxville Kidney Center Pllc
RECRUITING
Brentwood
Other Locations
Argentina
Novartis Investigative Site
RECRUITING
Buenos Aires
Republic of Korea
Novartis Investigative Site
RECRUITING
Seoul
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2031-06-25
Participants
Target number of participants: 223
Treatments
Experimental: zigakibart
Participants will receive zigakibart.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals