HSP-Glomerulonephritis Trial: MP vs CyA
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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MP pulses+prednisone or Cyclosporine A
Dept. of Pediatrics, Oulu University Hospital
Active, not recruiting
Oulu University Hospital
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00425724
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A systemic non-thrombocytopenic purpura caused by HYPERSENSITIVITY VASCULITIS and deposition of IGA-containing IMMUNE COMPLEXES within the blood vessels throughout the body, including those in the kidney (KIDNEY GLOMERULUS). Clinical symptoms include URTICARIA; ERYTHEMA; ARTHRITIS; GASTROINTESTINAL HEMORRHAGE; and renal involvement. Most cases are seen in children after acute upper respiratory infections.
Any form of purpura in which the PLATELET COUNT is decreased. Many forms are thought to be caused by immunological mechanisms.
A severe, rapidly fatal reaction occurring most commonly in children following an infectious illness. It is characterized by large, rapidly spreading skin hemorrhages, fever, or shock. Purpura fulminans often accompanies or is triggered by DISSEMINATED INTRAVASCULAR COAGULATION.
A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
An antineoplastic agent used primarily in combination with mechlorethamine, vincristine, and prednisone (the MOPP protocol) in the treatment of Hodgkin's disease.
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