Sibeprenlimab for IgA Nephropathy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and effectiveness of sibeprenlimab, an injectable medication, in patients with IgA Nephropathy who have been part of earlier studies. The medication likely helps manage symptoms or slow disease progression. Sibeprenlimab is being developed as a potential treatment for IgA nephropathy (IgAN).

Research Team

Eligibility Criteria

This trial is for people with a kidney condition called IgA Nephropathy who have a certain level of kidney function (eGFR ≥ 20 mL/min/1.73 m2) and completed previous trials without safety issues. It's not open to those who didn't finish the earlier studies or developed conditions that would have excluded them.

Inclusion Criteria

I completed a specific trial without safety issues and might benefit from sibeprenlimab.

Your kidney function, as measured by eGFR, is at least 20 mL/min/1.73 m2.

Exclusion Criteria

Subjects who have not completed participation in trials 417-201-00007 or VIS649-201.

You developed a condition after participating in previous trials that would have kept you from joining this trial.

Treatment Details

Interventions

Sibeprenlimab (Monoclonal Antibodies)

Trial OverviewThe study tests Sibeprenlimab, given as an injection under the skin every four weeks, to see how safe and effective it is over time for treating IgA Nephropathy.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Sibeprenlimab 400 mg s.c. q 4 weeksExperimental Treatment1 Intervention