NCT06740526PHASE2Recruiting
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Otsuka Pharmaceutical Development & Commercialization, Inc.
Start Date
11/19/2024
Completion Date
4/17/2029
Summary
This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.
Eligibility Criteria
Age Range: 16 years to No maximum
Inclusion Criteria:
1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
3. Participant has estimated glomerular filtration rate (eGFR) \> 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration \[CKD EPI\] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 \[CKiD U25\] eGFR equation for those younger than 18 years)
Exclusion Criteria:
1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
2. Participant has coexisting chronic kidney disease, other than IgAN.
3. Participant has a serum IgG value \<600 mg/dL at screening.
4. Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:
topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
6. Participants who would be likely to require prohibited concomitant therapy during the trial.
Interventions
DRUG
Sibeprenlimab
Conditions
IgA Nephropathy
Locations
Clinical Research Site 330
Denver, Colorado 80230
United States
Clinical Research Site 369
Boston, Massachusetts 21144
United States
Clinical Research Site 374
Dakota Dunes, South Dakota 57409
United States
Clinical Research Site 324
Houston, Texas 77054
United States
Clinical Research Site 305
Scarborough Village, Ontario M1H 3G4
Canada