Evaluating immunosuppressive therapy for IgA nephropathy in patients with advanced chronic kidney disease
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
PHASE3 · Air Force Military Medical University, China · NCT05510323
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 | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 208 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Air Force Military Medical University, China (other) |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Xi'an) |
| Trial ID | NCT05510323 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have explored immunosuppressive therapies for IgA nephropathy, but the specific combination and approach in this trial may offer novel insights.
Eligibility criteria
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 this trial is running
Xi'an
- AFMMU — Xi'an, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glomerulonephritis, IGA