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Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue

RecruitingPhase 2

A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy

Who can join

Ages 16 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Participants: 25 · Started: Nov 19, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06740526

Locations in the U.S.

ColoradoClinical Research Site 330, Denver
MassachusettsClinical Research Site 369, Boston
South DakotaClinical Research Site 374, Dakota Dunes
TexasClinical Research Site 324, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.