RecruitingPhase 3NCT05510323
Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD
Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease
Sponsor
Air Force Military Medical University, China
Enrollment
208 participants
Start Date
Feb 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria6
- 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
Interventions
DRUGPrednisolone
RAS blockade as much as tolerated or allowed
DRUGPrednisolone plus Cyclophosphamide
RAS blockade as much as tolerated or allowed
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05510323