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NCT Number: NCT06740526

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

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.

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Site 305, Scarborough Village, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sibeprenlimab

Drug

Sibeprelimab SC (Period 1)

Sibeprelimab SC (Period 2)

Primary outcomes

  1. Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52

    Time frame: From Baseline to Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

Otsuka Call Center

CONTACT

[email protected]

844-687-8522

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 18, 2024
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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