Phase 2/3 Open-Label Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy

Not Recruiting

Trial ID: NCT05248659

Purpose

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.

Official Title

A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Stanford Investigator(s)

Richard Lafayette
Richard Lafayette

Professor of Medicine (Nephrology)

Jackson Kim, MD
Jackson Kim, MD

Clinical Assistant Professor, Medicine - Nephrology

Eligibility

Inclusion Criteria:

* 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 Criteria:

* 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.

Intervention(s):

drug: Sibeprenlimab 400 mg s.c. Q4weeks

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Shiktj Dave
650-723-2240