Evaluating immunosuppressive therapy for IgA nephropathy in patients with advanced chronic kidney disease
Official title: Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
Run by Air Force Military Medical University, China · NCT05510323 · Data updated 2026-11-12
This study is testing if a combination of low-dose steroids and another medication can help people with IgA nephropathy and advanced kidney disease feel better and manage their symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 208 (estimated) |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Xi'an) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | August 2025 |
| Study ends | August 2028 |
| Registry record updated | May 6, 2024 |
| Trial ID | NCT05510323 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with biopsy-proven IgA nephropathy and significant proteinuria who are experiencing stage 3 or 4 chronic kidney disease.
✕Probably not a fit
Patients who have contraindications to immunosuppressive therapy or those with unstable kidney function for reasons other than IgA nephropathy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the long-term efficacy and safety of low-dose oral corticosteroids combined with cyclophosphamide therapy, as well as low-dose corticosteroids monotherapy, in patients with IgA nephropathy who have stage 3 or 4 chronic kidney disease. Participants will receive maximal renin-angiotensin system (RAS) inhibitor therapy alongside these treatments. The study focuses on patients with biopsy-proven IgA nephropathy and significant proteinuria despite optimal RAS blockade. The goal is to determine the best therapeutic approach to manage this condition effectively.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with IgA nephropathy and advanced chronic kidney disease.
How similar studies have gone: Other studies have explored immunosuppressive therapies for IgA nephropathy, but the specific combination and approach in this trial may offer novel insights.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Afmmu
Xi'an, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.