Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425724
Status:
COMPLETED
Last Update Posted:
2011-08-08
First Post:
2007-01-22
Brief Title:
HSP-glomerulonephritis Trial MP vs CyA
Sponsor:
Oulu University Hospital
Organization:
Oulu University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nephritisLimited 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 nephrosisnephritis the maintenance of renal function and the renal biopsy findings
Apart from corticosteroids immunosuppressive drugs such as azathioprine and cyclophosphamide have been used to treat severe HSP nephritisLimited 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 nephrosisnephritis 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 iv or cyclosporine A po The MP pulses will consist of three doses of methylprednisolone 30 mgkg iv 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 mgm2day po 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 mgkgday 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
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 iv or cyclosporine A po The MP pulses will consist of three doses of methylprednisolone 30 mgkg iv 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 mgm2day po 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 mgkgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None