Open-Label Extension Study of BION-1301 in IgA Nephropathy

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Chinook Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing BION-1301, a medicine that blocks a harmful protein, in adults with IgA nephropathy from a previous study. The medicine helps prevent kidney damage by stopping a specific protein from working.

Eligibility Criteria

Inclusion Criteria

Males must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through 10 weeks after the final dose of study drug)

Women of child-bearing potential (WOCBP) must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through 10 weeks after the final dose of study drug)

Able to provide signed informed consent

Exclusion Criteria

Received systemic corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy within 3 months prior to the first dose of study drug

Current malignancy or history of malignancy during the last 3 years

Type 1 or 2 diabetes

Treatment Details

Interventions

• BION-1301 (Monoclonal Antibodies)

Participant Groups

Group I: BION-1301 Q4W Experimental Treatment 1 Intervention

BION-1301 will be administered once every 4 weeks (Q4W) as an intravenous infusion.

Group II: BION-1301 Q2W Experimental Treatment 1 Intervention

BION-1301 will be administered once every 2 weeks (Q2W) as an intravenous infusion.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Amicis Research Center Northridge, CA

Who Is Running the Clinical Trial?

Chinook Therapeutics, Inc. Lead Sponsor

References