Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue (NCT06740526)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (7 items).
Location: Clinical Research Site 330 — Denver, Colorado
Age range: 16 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (5 Sites)
- Clinical Research Site 330 — Denver, Colorado
- Clinical Research Site 369 — Boston, Massachusetts
- Clinical Research Site 374 — Dakota Dunes, South Dakota
- Clinical Research Site 324 — Houston, Texas
- Clinical Research Site 305 — Scarborough Village, Ontario
📞 Contact the Study Coordinator
Phone: (844) 687-8522
Email: Otsuka-ProfessionalServices@otsuka-us.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in IgA Nephropathy
- A Study of Zigakibart in Adults With IgA Nephropathy — Birmingham, Alabama
- A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G — Lawrenceville, Georgia
- Study of BHV-1400 in IgA Nephropathy — Farmington, Connecticut
- Atrasentan in Patients With IgA Nephropathy — Birmingham, Alabama
- Atrasentan in Patients With Proteinuric Glomerular Diseases — Glendale, California
Explore by condition: All IgA Nephropathy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.