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Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

Active Not RecruitingPhase 3

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions: Immunoglobulin A Nephropathy

Interventions: Sibeprenlimab 400 mg, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Croatia

To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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- \<30 mL/min/1.73 m2), calculated using the 2021 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.

Locations (308)

Birmingham, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Granada Hills, California, United States
La Jolla, California, United States
La Mesa, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Dimas, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Lauderdale Lakes, Florida, United States
South Miami, Florida, United States
Atlanta, Georgia, United States
Lawrenceville, Georgia, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
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