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Taking people in ChinaPhase 3

Tests two immune-lowering treatments for IgA nephropathy with advanced kidney disease

Compares low-dose prednisolone alone with prednisolone plus cyclophosphamide in adults with IgA nephropathy.

Plain-language title generated from the registry record
Registry title: Efficacy of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 CKD

Key facts

Where
Xi'an, ChinaSee the site
Phase
Phase 3

Where in China

  • AFMMUXi'an, ChinaTaking people

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Trial details

Who runs it
Air Force Military Medical University, China
Trial code
NCT05510323
Record updated
6 May 2024
Original description
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.Read full original descriptionShow less

Efficacy and Safety of Immunosuppressive Therapy for IgA Nephropathy With Stage 3 or 4 Chronic Kidney Disease

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.

Inclusion: 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: Indication or contraindication for immunosuppressive therapy with corticosteroids; Use of corticosteroids and other immunosuppressive drugs within the last 1 year; Under 18 years old; Current unstable kidney function for other reasons; Patients with secondary IgAN; Patients who are unlikely to comply with the study protocol in the view of the treating physician.

ClinicalTrials.gov NCT05510323