Safety and Efficacy Study of VIS649 for IgA Nephropathy
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) Nephropathy
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants With Adverse Events Graded by Severity
Time frame: Baseline to End of Study (16 months)
Changes From Baseline in Clinical Laboratory Tests
Time frame: Baseline to End of Study (16 months)
Clinically Meaningful Changes From Baseline in Vital Signs
Time frame: Baseline to End of Study (16 months)
Clinically Significant Physical Examinations
Time frame: Baseline to End of Study (16 months)
Secondary Endpoints
Change From Baseline in uPCR: Months 9 and 16
Change in 24-hour Urine Protein Excretion: Months 12 and 16
Participants Achieving a Greater Than or Equal to 30% Decline From Baseline in uPCR at Months 9, 12, and 16
Eligibility Criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant is a male or female ≥ 18 years of age at the time of signing the informed consent. 2. Participant must have biopsy-confirmed IgAN. 3. Participant has medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening. Participants should optimally be on at least 50% of the maximum recommended dose of these agents; however, if a participant is on their maximally tolerated dose (and this is \< 50% of the maximum recommended dose) and has been on this dose for at least 3 months, they may be enrolled. Participants who are unable to tolerate ACEI/ARB therapy may be eligible for participation in the study if their overall management of IgAN, including BP control, is as per local SOC and applicable guidelines. 4. Participants must have scre…
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