|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 22, 2007 | ||||
| Last Updated Date | January 22, 2007 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
Need for additional medication | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | HSP-Glomerulonephritis Trial: MP vs CyA | ||||
| Official Title ICMJE | |||||
| Brief 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. |
||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Purpura, Schoenlein-Henoch | ||||
| Intervention ICMJE | Drug: MP pulses+prednisone or Cyclosporine A | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Completion Date | February 2007 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 2 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Finland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00425724 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 25600 | ||||
| Study Sponsor ICMJE | Oulu University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Oulu University Hospital | ||||
| Verification Date | January 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||