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
  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: Methylprednisolone pulses plus prednisone versus Cyclosporine A
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Oulu University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Need for additional medication [ Time Frame: 24 mo ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2000
Study Completion Date: February 2011
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425724

Locations
Finland
Dept. of Pediatrics, Oulu University Hospital
Oulu, Finland, 90029 OYS
Sponsors and Collaborators
Oulu University Hospital
Investigators
Principal Investigator: Matti Nuutinen, M.D., Ph.D. Dept. of Pediatrics, Oulu University Hospital
  More Information

Publications:
Responsible Party: Dr. Matti Nuutinen, Oulu Univ. Hospital, Oulu Univ. Hospital
ClinicalTrials.gov Identifier: NCT00425724     History of Changes
Other Study ID Numbers: 25600
Study First Received: January 22, 2007
Last Updated: August 5, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Oulu University Hospital:
proteinuria
nephritis
nephrotic syndrome
glomerulonephritis

Additional relevant MeSH terms:
Glomerulonephritis
Purpura, Schoenlein-Henoch
Nephritis
Kidney Diseases
Urologic Diseases
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Hypersensitivity
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Methylprednisolone acetate
Prednisolone acetate
Prednisone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Cyclosporins
Cyclosporine

ClinicalTrials.gov processed this record on October 16, 2014