drugset / Trial / NCT00425724

HSP-glomerulonephritis Trial: MP vs CyA

NCT00425724

Phase 4 Completed 20 enrolled Oulu University Hospital
RandomizedSingle-groupOpen-labelTreatment

Summary

No curative treatment of severe HSP nephritis is known. Apart from corticosteroids, immunosuppressive drugs, such as azathioprine and cyclophosphamide, have been used to treat severe HSP nephritis.Limited patient series treated with these drugs have been described, but there are no reports of controlled trials. Cyclosporine A have been used to treat corticosteroid-resistant or corticosteroid-dependent nephrosis. (11) Cyclosporine A has also been used to treat HSP nephritis, but as far as we know, there are no publications reporting such trials. The aim of the study is to compare MP pulses and cyclosporine A for their efficacy in the treatment of HSP nephritis. The efficacy of the two treatments will be assessed on the basis of the duration of nephrosis/nephritis, the maintenance of renal function and the renal biopsy findings.

Timeline

Start
2000-01
Primary completion
2007-02
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide 5 mg/kg Oral
Subject Methylprednisolone Other / unclassified 30 mg/kg Intravenous
Subject Prednisone Other / unclassified 30 mg/m2 Oral