Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07770815

Trial of Sibeprenlimab in Children and Adolescents With Immunoglobulin A Nephropathy (IgAN)

This Phase 3, open-label study will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of sibeprenlimab administered subcutaneously every 4 weeks in pediatric participants aged 2 to 17 years with IgA nephropathy (IgAN). Sibeprenlimab will be administered as an add-on to standard of care therapy consisting of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs).

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

  • Source-verified, biopsy-confirmed IgA nephropathy (IgAN).
  • Receiving a stable and maximally tolerated dose of authorized angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) for at least 12 weeks.
  • Participants receiving a stable dose of sodium-glucose cotransporter-2 inhibitor (SGLT2i) therapy for IgAN, if available, in addition to ACEIs and/or ARBs, must have initiated SGLT2i treatment for at least 12 weeks.
  • Participants must have a urine protein/creatinine ratio (uPCR) ≥ 0.75 grams per gram (g/g), as measured from the geometric mean of 3 first void spot urine samples (collected within the screening window prior to Dose 1).
  • Estimated glomerular filtration rate (eGFR) ≥ 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2).
  • No evidence of coexisting chronic kidney disease other than IgAN.
  • Serum immunoglobulin G (IgG) ≥ 600 mg/dL at screening.
  • Kidney biopsy findings not demonstrating additional pathological features inconsistent with IgAN.

Treatment and study plan

Sibeprenlimab

Drug

Sibeprenlimab is administered subcutaneously once every 4 weeks for 48 weeks at a weight-based dose

Standard of care

Drug

Standard of care therapy consists of angiotensin converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs)

Primary outcomes

  1. Ratio of Urine Protein-to-Creatinine Ratio (uPCR) at Week 40 Compared With Baseline Using First-void Spot Urine Samples

    Time frame: Baseline, Week 40

  2. Serum Concentration of Sibeprenlimab Through Week 52

    Time frame: Baseline through Week 52

  3. Change From Baseline in Serum Immunoglobulin A (IgA) Through Week 52

    Time frame: Baseline through Week 52

Secondary outcomes

  1. Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Study Discontinuations Due to Adverse Events Through Week 60

    Time frame: Baseline through Week 60

  2. Number of Participants With Clinically Significant Changes in Vital Signs Through Week 60

    Time frame: Baseline through Week 60

  3. Number of Participants With Clinically Significant Changes in Physical Examination Findings Through Week 60

    Time frame: Baseline through Week 60

  4. Number of Participants With Clinically Significant Changes in Laboratory Assessments Through Week 60

    Time frame: Baseline through Week 60

    Laboratory assessments include hematology, serum chemistry, and urine laboratory parameters.

  5. Number of Injection Site Reactions Through Week 52

    Time frame: Baseline through Week 52

  6. Number of Participants With Anti-Drug Antibody (ADA) From Baseline Through Week 60

    Time frame: Baseline through Week 60

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 3, Open-label, Single-arm, Repeat-dose Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Sibeprenlimab Administered Subcutaneously in Children and Adolescents With Immunoglobulin A Nephropathy

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.