NCT05510323 Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
| NCT ID | NCT05510323 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Air Force Military Medical University, China |
| Condition | Glomerulonephritis, IGA |
| Study Type | INTERVENTIONAL |
| Enrollment | 208 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 208 participants in total. It began in 2024-02-01 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this clinical trial is to evaluate the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy and low-dose corticosteroids monotherapy, on a background of maximal RAS inhibitor therapy, for IgA nephropathy with stage 3 or 4 chronic kidney disease.
Eligibility Criteria
Inclusion Criteria: * Biopsy-proven IgA nephropathy; * Proteinuria ≥1.0g/day while receiving maximum tolerated dose of RAS blockade; * Estimated glomerular filtration rate 15-60 ml/min/1.73/m2. Exclusion Criteria: * Indication or contraindication for immunosuppressive therapy with corticosteroids * Use of corticosteroids and other immunosuppressive drugs within the last 1 year * Current unstable kidney function for other reasons * Under 18 years old * Patients with secondary IgAN * Patients who are unlikely to comply with the study protocol in the view of the treating physician
Frequently Asked Questions
Who can join the NCT05510323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Glomerulonephritis, IGA. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05510323 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 208 participants.
Is NCT05510323 currently recruiting?
Yes, NCT05510323 is actively recruiting participants. Visit ClinicalTrials.gov or contact Air Force Military Medical University, China to inquire about joining.
Where is the NCT05510323 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT05510323 clinical trial?
NCT05510323 is sponsored by Air Force Military Medical University, China. The trial plans to enroll 208 participants.