Immunoglobulin A Nephropathy Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Verified date | March 2024 |
Source | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a phase 3 study to evaluate effects on proteinuria and glomerular filtration rate of sibeprenlimab 400 mg subcutaneously (s.c.) Q 4 weeks in adults with IgAN who are receiving maximally tolerated standard-of-care therapy.
Status | Active, not recruiting |
Enrollment | 530 |
Est. completion date | December 30, 2026 |
Est. primary completion date | December 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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- <30 mL/min/1.73 m2), calculated using the CKD-EPI equation.) Exclusion Criteria: - Secondary forms of IgAN or IgA vasculitis. - Coexisting chronic kidney disease other than IgAN. - Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable. - Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 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. |
Country | Name | City | State |
---|---|---|---|
United States | For additional information regarding sites, contact 844-687-8522 | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Otsuka Pharmaceutical Development & Commercialization, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary protein to creatinine ratio (uPCR) in a 24-hour collection | At 9 months | ||
Secondary | Annualized rate of change from baseline (slope) of eGFR | Over 24 months | ||
Secondary | Proportion of subjects achieving urine total protein < 1.0 g/day and = 25% reduction from baseline. | At 12 months | ||
Secondary | Annualized slope of eGFR | Over 12 months |
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