Atrasentan in Patients With IgA Nephropathy
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Atrasentan in Patients With IgA Nephropathy at Risk of Progressive Loss of Renal Function
Sponsor: Chinook Therapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Double-blind period: Change in proteinuria
Time frame: Up to Week 36 or approximately 9 months
Open-label period: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From open-label baseline up to end of treatment visit, 48 weeks
Open-label period: Number of Subjects With Adverse Events of Special Interest (AESI) Including Events of Fluid Overload
Time frame: From open-label baseline up to end of treatment visit, 48 weeks
Secondary Endpoints
Double-blind period: Change in eGFR
Double-blind period: Percent of subjects meeting the first composite endpoint
Double-blind period: Percent of subjects meeting the second composite endpoint
Eligibility Criteria
Inclusion Criteria: Double-Blind period: * Biopsy-proven IgA nephropathy. * Receiving a maximally tolerated dose of RAS inhibitor therapy (ACEi or ARB) that has been stable for at least 12 weeks. Exceptions from this requirement will be made for subjects who are unable to tolerate RAS inhibitor therapy. * Total urine protein ≥1 g/day as measured via 24-hour urine collection by central laboratory at Screening. * eGFR of at least 30 mL/min/1.73 m\^2 at Screening based on the CKD-EPI equation. * Willing and able to provide informed consent and comply with all study requirements. * SGLT2i Stable Stratum Only - Receiving a stable dose of an SGLT2i (per Investigator choice) in addition to a maximally tolerated and optimized dose of a RAS inhibitor that has been stable for at least 12 weeks prior to Screening. * All fertile men and WOCBP who engage in heterosexual intercourse must be willing to abide with highly effective forms of contraception, as specified in the protocol, throughout the …
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