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Active Not Recruiting
NCT05248646
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
Conditions: Immunoglobulin A Nephropathy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 530
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Location: University of Alabama at Birmingham - Site #336 Birmingham Alabama
Summary
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
Eligibility Criteria
Inclusion Criteria:
* Male and female patients ≥ 18 years of age .
* Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
* Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
* Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
* eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- \ 50% tubulo-interstitial fibrosis, or crescents in \> 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
* Nephrotic syndrome
* Serum IgG \< 600 mg/dL at screening.
* Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
* Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
* Chronic infectious disease, or acute infectious disease at time of screening.
* Type 1 diabetes, or poorly controlled Type 2 diabetes
* Uncontrolled hypertension
The protocol provides additional information about these and other inclusion and exclusion criteria.
Source: ClinicalTrials.gov (NCT05248646). StuddyBuddy aggregates publicly available trial information.