NCT00425724|CompletedPhase 4
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Sponsor study identifier
interventional
20
1 country
1
Study Start
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Study Completion
February 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
January 22, 2007
Actual (reported)January 23, 2007
Actual (reported)February 2007
Actual (reported)February 2011
Actual (reported)Disappearance of proteinuria/ hematuria
24 mo
Renal function (measured by Cr-EDTA-Cl- GFR)
24 mo
Renal biopsy findings
24 mo
Need for additional medication
24 mo
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.
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Grouped treatment entry
Methylprednisolone pulses plus prednisone versus Cyclosporine A
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordDept. of Pediatrics, Oulu University Hospital
Oulu, 90029 OYS, Finland
Jauhola O, Ronkainen J, Autio-Harmainen H, Koskimies O, Ala-Houhala M, Arikoski P, Holtta T, Jahnukainen T, Rajantie J, Ormala T, Nuutinen M. Cyclosporine A vs. methylprednisolone for Henoch-Schonlein nephritis: a randomized trial. Pediatr Nephrol. 2011 Dec;26(12):2159-66. doi: 10.1007/s00467-011-1919-5. Epub 2011 May 28.
Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
Matti Nuutinen, M.D., Ph.D.
Dept. of Pediatrics, Oulu University Hospital
First Submitted
January 22, 2007
First Posted
January 23, 2007
Study Start
January 2000
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura
Contact the study team to confirm eligibility.
Study Completion
February 2011
Actual (reported)Last Updated
August 8, 2011
Record last verified: 2011-08
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Source: ClinicalTrials.gov.
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