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RecruitingPhase 2

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

Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT06740526

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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
Trial of the Impact of Sibeprenlimab on Immunoglobulin A… (NCT06740526) | Bored Studies