Status:
ENROLLING_BY_INVITATION
Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Immunoglobulin A Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a phase 2/3 open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) in subjects with IgAN.
Detailed Description
This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN. Eligible subje...
Eligibility Criteria
Inclusion
- Subjects who completed Trial 417-201-00007 or VIS649-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
- eGFR ≥ 20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion
- Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.
- Subjects who, following enrollment in trials 417-201-00007 or VIS649-201 developed a condition or characteristic that would have excluded them from participation in these trials.
Key Trial Info
Start Date :
April 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2028
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05248659
Start Date
April 5 2022
End Date
December 28 2028
Last Update
December 9 2024
Active Locations (1)
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1
For additional information regarding sites, contact 844-687-8522
New York, New York, United States, 10001