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Recruiting NCT06740526

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

Phase II Interventional IgA Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sibeprenlimab.
Who it may be relevant to
Registry conditions: IgA Nephropathy. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug Sibeprenlimab
    Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)

Primary outcome measures

  • Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52 [Time frame: From Baseline to Week 52]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • Clinical Research Site 330 — Denver
  • Clinical Research Site 369 — Boston
  • Clinical Research Site 374 — Dakota Dunes
  • Clinical Research Site 324 — Houston
Canada · 1 center
  • Clinical Research Site 305 — Scarborough Village

Identifiers

NCT: NCT06740526 · 417-201-00060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗