Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

• Status: Not yet recruiting
• Trial end date: 2028-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Military Medical University, China
• Treatments: Cyclophosphamide; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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