Clinical Trials in Spain / NCT05248646
Active, not recruiting
Phase 3
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
NCT05248646 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Immunoglobulin A Nephropathy
Investigational drug(s) / intervention(s)
Sibeprenlimab 400 mg →Placebo
Sibeprenlimab 400 mg: Solution for Injection
Placebo: Placebo s.c. q 4 weeks
Study summary
To Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Subjects with Primary Immunoglobulin A Nephropathy
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Urinary protein to creatinine ratio (uPCR) in a 24-hour collection — At 9 months
Trial sites (308)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham - Site #336 | Birmingham | Alabama | |
| Mayo Clinic Arizona - Site #363 | Phoenix | Arizona | |
| University of Arkansas for Medical Sciences - Site #353 | Little Rock | Arkansas | |
| Amicis Research Center - Site #341 | Granada Hills | California | |
| University of CA San Diego - Site #351 | La Jolla | California | |
| California Institute of Renal Research - Site #371 | La Mesa | California | |
| Loma Linda University Health Care Clinical Trial Center Clinic - Site #372 | Loma Linda | California | |
| Academic Medical Research Institute - Site #333 | Los Angeles | California | |
| Kaiser Permanente - Southern California Permanente Medical Group SCPMG - LAMC - Site #325 | Los Angeles | California | |
| Stanford University - Site #370 | Palo Alto | California | |
| North America Research Institute - Site #335 | San Dimas | California | |
| University of California, San Francisco - Site #377 | San Francisco | California | |
| Colorado Kidney Care PC - Site #330 | Denver | Colorado | |
| Mayo Clinic in Florida - Site #321 | Jacksonville | Florida | |
| South Florida Research Institute - Site #323 | Lauderdale Lakes | Florida | |
| Columbus Research Group - Site #376 | South Miami | Florida | |
| Fides Clinical Research North Atlanta Kidney Specialists - Site #373 | Atlanta | Georgia | |
| Georgia Nephrology - Site #356 | Lawrenceville | Georgia | |
| University of Iowa Hospitals & Clinics - Site #359 | Iowa City | Iowa | |
| Kansas Nephrology Associates - Site #322 | Wichita | Kansas | |
| Ochsner Medical Center - Site #334 | New Orleans | Louisiana | |
| University of Maryland - Site #355 | Baltimore | Maryland | |
| MGH Harvard - Site #369 | Boston | Massachusetts | |
| Brigham and Women's Hospital, Division of Renal Medicine - Site #379 | Boston | Massachusetts | |
| Tufts Medical Center - Site #349 | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center - Site #337 | Boston | Massachusetts | |
| MGH Harvard - Site #369 | Boston | Massachusetts | |
| Brigham and Women's Hospital, Division of Renal Medicine - Site #379 | Boston | Massachusetts | |
| Tufts Medical Center - Site #349 | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center - Site #337 | Boston | Massachusetts | |
| UMASS Memorial Medical Center - Site #331 | Worcester | Massachusetts | |
| UMASS Memorial Medical Center - Site #331 | Worcester | Massachusetts | |
| St. Clair Nephrology Research - Site #320 | Roseville | Michigan | |
| University of Minnesota - Site #345 | Minneapolis | Minnesota | |
| Mayo Clinic - Rochester - Site #332 | Rochester | Minnesota | |
| University of Nebraska Medical Center - Site #347 | Omaha | Nebraska | |
| Davita Clinical Research - Las Vegas - Site #327 | Las Vegas | Nevada | |
| Northwell Health - North Shore University Hospital NSUH - Site #346 | Great Neck | New York | |
| New York University Grossman School of Medicine - Site #362 | New York | New York | |
| Jacobi Medical Center - Site #364 | The Bronx | New York |
+ 268 more sites — see the full list on the official registry below.
More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in Spain
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
Enrolling by invitation
A Trial to Evaluate the Efficacy and Safety of Sibeprenlimab Administered Subcutaneously in Participants With Sjögren's
Active, not recruiting
Other trials for the same condition
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
Active, not recruiting
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Active, not recruiting
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
Enrolling by invitation
Atrasentan in Patients With IgA Nephropathy
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05248646 on ClinicalTrials.gov ↗ ← All trials in Spain