HSP-glomerulonephritis Trial: MP vs CyA
Condition: Purpura, Schoenlein-Henoch
MeSH terms: Glomerulonephritis; IgA Vasculitis; Purpura
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Using a prospective, randomised, open-labelled design, MP pulse treatment and cyclosporine A
      treatment will be compared for their efficacy in the treatment of severe HSP
      glomerulonephritis.

      The trial will be a national multi-centre trial that involves all Finnish university
      hospitals, a few Finnish central hospitals.

      The HSP patients with crescent HSP glomerulonephritis (ISKDC class III or IV) diagnosed by
      renal biopsy or with a renal biopsy finding of ISKDC class II + a distinct nephrotic syndrome
      will be included. Most of the patients will be recruited from a series collected by the same
      authors to study the prevention of HSP nephritis (see Effect of prednisone treatment on the
      symptoms of HSP disease and the development of glomerulonephritis).

      The patients will be randomised to receive either MP pulses i.v. or cyclosporine A p.o. The
      MP pulses will consist of three doses of methylprednisolone 30 mg/kg i.v. given over a period
      of one week in hospital. On the intermediate days and for a month after the MP pulses, the
      patients will be given prednisone 30 mg/m2/day p.o., after which the prednisone medication
      will be gradually tapered over 3 months. The patients randomised into the cyclosporine A
      group will receive an initial dose of 5 mg/kg/day, after which the dosage will be titrated to
      an optimal therapeutic level by monitoring the B-Cya concentration. The cyclosporine A
      treatment will be continued for 12 months.
    

Intervention name(s): Methylprednisolone pulses plus prednisone versus Cyclosporine A
Intervention type(s): Drug
Intervention description(s): The patients will be randomised to receive either MP pulses i.v. or cyclosporine A p.o. The MP pulses will consist of three doses of methylprednisolone 30 mg/kg i.v. given over a period of one week in hospital. On the intermediate days and for a month after the MP pulses, the patients will be given prednisone 30 mg/m2/day p.o., after which the prednisone medication will be gradually run down over 3 months. The patients randomised into the cyclosporine A group will receive an initial dose of 5 mg/kg/day, after which the dosage will be titrated to an optimal therapeutic level by monitoring the B-Cya concentration. The cyclosporine A treatment will be continued for 12 months.
Intervention MeSH terms: Cyclosporine; Prednisone; Methylprednisolone; Cyclosporins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: proteinuria; nephritis; nephrotic syndrome; glomerulonephritis