This study is in progress, not accepting new patients

Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)

a study on IgA Nephropathy Glomerulonephritis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
study ends around
Principal Investigator
by Raymond Hsu (ucsf)
Headshot of Raymond Hsu
Raymond Hsu

Description

Summary

To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.

Details

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of sibeprenlimab 400 mg administered SC Q 4 weeks compared to placebo in patients with IgAN. The primary objective is to compare the relative change from baseline in the urinary protein to creatinine ratio (uPCR) in 24-hour urine collections, after 9 months of treatment. The key secondary objective is to compare the annualized rate of change from baseline (slope) of estimated glomerular filtration rate (eGFR) after approximately 24 months of treatment. There will be one main cohort comprised of approximately 450 subjects with source-verified biopsy-confirmed IgAN and eGFR ≥ 30 mL/min/1.73 m2. An additional exploratory cohort will be comprised of up to 20 subjects with source-verified biopsy confirmed IgAN and eGFR of 20 to < 29 mL/min/1.73 m2.

Keywords

Immunoglobulin A Nephropathy, IgAN, Sibeprenlimab, VIS649, IGA Glomerulonephritis, Sibeprenlimab 400 mg, Sibeprenlimab 400 mg s.c. q 4weeks

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male and female patients ≥ 18 years of age .
  • Biopsy-confirmed IgAN. (Patients with an eGFR of 30 to 45 mL/min/1.73m2 must have had a kidney biopsy performed within 36 months of the screening visit).
  • Stable and maximally tolerated dose of ACEI and/or ARB for at least 3 months prior to screening. Patients who are on a stable dose of SGLT2i may participate if treatment was initiated ≥3 months prior to screening. Patients who are unable to take an ACEI or ARB may participate if their overall management conforms with standards of care and other protocol requirements.
  • Screening urine protein/creatinine ratio (uPCR) ≥ 0.75 g/g or urine protein ≥ 1.0 g/day
  • eGFR ≥ 30 mL/min/1.73 m2, (for the exploratory cohort only: eGFR 20- <30 mL/min/1.73 m2), calculated using the 2021 CKD-EPI equation

You CAN'T join if...

  • Secondary forms of IgAN or IgA vasculitis.
  • Coexisting chronic kidney disease other than IgAN.
  • Kidney biopsy findings in addition to IgAN including those of diabetic nephropathy, membranous nephropathy, or lupus nephritis. Hypertensive vascular changes are acceptable.
  • Kidney biopsy MEST or MEST-C score of T2 or C2 (Oxford IgAN classification). If MEST-scoring was not performed, the presence of > 50% tubulo-interstitial fibrosis, or crescents in > 25% of glomeruli is exclusionary. This does not apply to the exploratory cohort.
  • Nephrotic syndrome
  • Serum IgG < 600 mg/dL at screening.
  • Chronic systemic immunosuppression, including glucocorticoids, within 16 weeks of randomization
  • Participation in another interventional clinical trial and receipt of another investigational drug within 30 days prior to the administration of IMP or 5 half-lives from last investigational drug administration, whichever is longer.
  • Chronic infectious disease, or acute infectious disease at time of screening.
  • Type 1 diabetes, or poorly controlled Type 2 diabetes
  • Uncontrolled hypertension

The protocol provides additional information about these and other inclusion and exclusion criteria.

Locations

  • University of CA San Diego - Site #351
    La Jolla California 92037 United States
  • University of California, San Francisco - Site #377
    San Francisco California 94143 United States
  • Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325
    Los Angeles California 90027 United States
  • California Institute of Renal Research - Site #371
    La Mesa California 91942 United States
  • Amicis Research Center - Site #341
    Granada Hills California 91344 United States
  • Academic Medical Research Institute - Site #333
    Los Angeles California 90022 United States
  • Stanford University - Site #370
    Palo Alto California 94304 United States

Lead Scientist at University of California Health

  • Raymond Hsu (ucsf)
    Professor, Medicine, School of Medicine. Authored (or co-authored) 53 research publications. Research interests: Acute kidney injury · blood pressure · chronic kidney disease · epidemiology · dialysis · end-stage renal disease · health disparities · hypertension · nephrology · glomerular disease · onco-nephrology · nephrotic syndrome · RPGN · outcomes research

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Links
Otsuka Clinical Trial Website Otsuka Clinical Trial Transparency
ID
NCT05248646
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 530 people participating
Last Updated