Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT06740526
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 16+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 25
- US sites recruiting
- 4
- Study start
- November 19, 2024
- Record last updated
- April 6, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Sibeprenlimab
Conditions: IgA Nephropathy
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
- Source-verified kidney biopsy confirmed diagnosis of IgAN.
- 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
- Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
- Participant has coexisting chronic kidney disease, other than IgAN.
- Participant has a serum IgG value \<600 mg/dL at screening.
- 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).
- Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
- Participants who would be likely to require prohibited concomitant therapy during the trial.
Recruiting US locations
Clinical Research Site 330
Denver, CO 80230
Site contact: Otsuka Call Center
Clinical Research Site 369
Boston, MA 21144
Site contact: Otsuka Call Center
Clinical Research Site 374
Dakota Dunes, SD 57409
Site contact: Otsuka Call Center
Clinical Research Site 324
Houston, TX 77054
Site contact: Otsuka Call Center
Study contacts (from the official record)
- Otsuka Call Center · 844-687-8522 · Otsuka-ProfessionalServices@otsuka-us.com