|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsor: | Oulu University Hospital |
|---|---|
| Information provided by: | Oulu University Hospital |
| ClinicalTrials.gov Identifier: | NCT00425724 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Purpura, Schoenlein-Henoch |
Drug: MP pulses+prednisone or Cyclosporine A |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | February 2007 |
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.
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Finland | |
| Dept. of Pediatrics, Oulu University Hospital | |
| Oulu, Finland, 90029 OYS | |
| Principal Investigator: | Matti Nuutinen, M.D., Ph.D. | Dept. of Pediatrics, Oulu University Hospital |
More Information
| Study ID Numbers: | 25600 |
| Study First Received: | January 22, 2007 |
| Last Updated: | January 22, 2007 |
| ClinicalTrials.gov Identifier: | NCT00425724 History of Changes |
| Health Authority: | Finland: Finnish Medicines Agency |
|
proteinuria nephritis nephrotic syndrome glomerulonephritis |
|
Anti-Infective Agents Skin Manifestations Glomerulonephritis Immune Complex Diseases Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Vasculitis, Hypersensitivity Hemostatic Disorders Cyclosporins Signs and Symptoms Hypersensitivity Hemorrhagic Disorders Urologic Diseases |
Therapeutic Uses Antifungal Agents Cardiovascular Diseases Kidney Diseases Dermatologic Agents Purpura Vasculitis Immune System Diseases Hematologic Diseases Blood Coagulation Disorders Purpura, Schoenlein-Henoch Vascular Diseases Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |
