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HSP-glomerulonephritis Trial: MP vs CyA

This study has been completed.
Sponsor:
Information provided by:
Oulu University Hospital
ClinicalTrials.gov Identifier:
NCT00425724
First received: January 22, 2007
Last updated: August 5, 2011
Last verified: August 2011

January 22, 2007
August 5, 2011
January 2000
February 2007   (final data collection date for primary outcome measure)
  • Disappearance of proteinuria/ hematuria [ Time Frame: 24 mo ] [ Designated as safety issue: No ]
  • Renal function (measured by Cr-EDTA-Cl- GFR) [ Time Frame: 24 mo ] [ Designated as safety issue: No ]
  • Renal biopsy findings [ Time Frame: 24 mo ] [ Designated as safety issue: No ]
  • Disappearance of proteinuria/ hematuria
  • Renal function (measured by Cr-EDTA-Cl- GFR)
  • Renal biopsy findings
Complete list of historical versions of study NCT00425724 on ClinicalTrials.gov Archive Site
Need for additional medication [ Time Frame: 24 mo ] [ Designated as safety issue: No ]
Need for additional medication
Not Provided
Not Provided
 
HSP-glomerulonephritis Trial: MP vs CyA
Not Provided

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Purpura, Schoenlein-Henoch
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.
Not Provided
Jauhola O, Ronkainen J, Autio-Harmainen H, Koskimies O, Ala-Houhala M, Arikoski P, Hölttä T, Jahnukainen T, Rajantie J, Ormälä T, Nuutinen M. Cyclosporine A vs. methylprednisolone for Henoch-Schönlein nephritis: a randomized trial. Pediatr Nephrol. 2011 Dec;26(12):2159-66. doi: 10.1007/s00467-011-1919-5. Epub 2011 May 28. Erratum in: Pediatr Nephrol. 2011 Dec;26(12):2263-4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2011
February 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • On the basis of a renal biopsy, the patient has been diagnosed for crescentic HSP glomerulonephritis of ISKDC grade III or IV or HSP glomerulonephritis of ISKDC grade II + a definite nephrotic syndrome (proteinuria > 40 mg/m2/h).

Exclusion Criteria:

  • The child is on regular medication known to interact with cyclosporine. Such medication includes cisapride, phenytoin, phenobarbital, carbamazepine, digoxin and anti-inflammatory pain medication.
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00425724
25600
Not Provided
Dr. Matti Nuutinen, Oulu Univ. Hospital, Oulu Univ. Hospital
Oulu University Hospital
Not Provided
Principal Investigator: Matti Nuutinen, M.D., Ph.D. Dept. of Pediatrics, Oulu University Hospital
Oulu University Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP