Clinical Trials in the UK / NCT06740526
Recruiting
Phase 2
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
NCT06740526 · tracked via the Priya Life Science UK tracker
Condition(s) studied
IgA Nephropathy
Investigational drug(s) / intervention(s)
Sibeprenlimab: Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)
Study summary
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.
Eligibility
Inclusion Criteria:
1. Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
2. Source-verified kidney biopsy confirmed diagnosis of IgAN.
3. 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:
1. Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
2. Participant has coexisting chronic kidney disease, other than IgAN.
3. Participant has a serum IgG value \<600 mg/dL at screening.
4. 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).
5. Participant has uncontrolled hypertension (defined as systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg).
6. Participants who would be likely to require prohibited concomitant therapy during the trial.
Primary outcome measure(s)
- Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52 — From Baseline to Week 52
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinical Research Site 330 | Denver | Colorado | Recruiting |
| Clinical Research Site 369 | Boston | Massachusetts | Recruiting |
| Clinical Research Site 374 | Dakota Dunes | South Dakota | Recruiting |
| Clinical Research Site 324 | Houston | Texas | Recruiting |
| Clinical Research Site 305 | Scarborough Village | Ontario | Recruiting |
More Otsuka Pharmaceutical Development & Commercialization, Inc. trials in the UK
Trial of Sibeprenlimab in the Treatment of A Nephropathy (IgAN)
Active, not recruiting
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)
Enrolling by invitation
Other trials for the same condition
Atrasentan in Patients With IgA Nephropathy
Active, not recruiting
Study of BHV-1400 in IgA Nephropathy
Recruiting
Atrasentan in Patients With Proteinuric Glomerular Diseases
Active, not recruiting
A Study of Zigakibart in Adults 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 NCT06740526 on ClinicalTrials.gov ↗ ← All trials in the UK