HSP-glomerulonephritis Trial: MP vs CyA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Research of Standard Diagnosis and Treatment for HSPN in Children

NCT02532777

Henoch-Schoenlein Purpura Nephritis

UNKNOWN PHASE2

Mycophenolate Mofetil (MMF) Versus Intravenous CTX Pulses in the Treatment of Adult Severe HSPN

NCT00301613

Henoch-Schoenlein Purpura Nephritis

COMPLETED NA

Efficacy of Steroid Versus Steroid Plus Cyclophosphamide for Severe Henoch-Schoenlein Purpura

NCT00190229

Henoch-Schoenlein Purpura

COMPLETED NA

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

NCT03647852

Henoch-Schönlein Purpura

RECRUITING NA

"Steroids and Azathioprine Versus Steroids Alone in IgAN"

NCT00755859

IGA Nephropathy

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Purpura, Schoenlein-Henoch

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No