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HSP-glomerulonephritis Trial: MP vs CyA

NCT00425724 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-08-08

No results posted yet for this study

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.

Conditions

  • Purpura, Schoenlein-Henoch

Interventions

DRUG

Methylprednisolone pulses plus prednisone versus Cyclosporine A

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.

Sponsors & Collaborators

  • Oulu University Hospital

    lead OTHER

Principal Investigators

  • Matti Nuutinen, M.D., Ph.D. · Dept. of Pediatrics, Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Primary Completion
2007-02-28
Completion
2011-02-28

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00425724 on ClinicalTrials.gov