FIVE-YEAR SINGLE-BLIND, PHASE III EFFECTIVENESS RANDOMISEDACTIVELY CONTROLLED CLINICAL TRIAL IN NEW ONSET JUVENILESYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS: ORALCYCLOPHOSPHAMIDE VERSUS HIGH DOSE INTRAVENOUSCYCLOPHOSPHAMIDE VERSUS INTERMEDIATE DOSE INTRAVENOUSCYCLOPHOSPHAMIDE

• Conditions: SYSTEMIC LUPUS ERYTHEMATOSUS NEPHRITIS; MedDRA version: 8.1Level: LLTClassification code 10029142Term: Nephritis systemic lupus erythematosus

• Registration Number: EUCTR2005-003957-28-DK
• Lead Sponsor: Istituto Giannina Gaslini

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-20
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

1)Newly diagnosed children with untreated and biopsy proven revised WHO Class III, IV
proliferative lupus nephritis and 24 hour proteinuria = 500 mg/day. The kidney biopsy
specimen will be read by the renal pathologists of the participating centres (light and
immunofluorescence) (54). Slides of paraffin-embedded sections from all patients will
be re-viewed by a blinded a renal pathologist at the PRINTO coordinating centre.
2) Diagnosis of JSLE according to the ACR revised classification criteria (57);
3) Age at enrolment = 18 years.
4) Female of child-bearing potential must have a negative pregnancy test at the beginning
of the trial, and then every 3 months. If sexually active, they must agree to use adequate
contraception, throughout study participation, and must have no intention of conceiving
during the course of the study. Post-pubertal males must have no plans to father a child
during the study and agree to use adequate birth control methods if sexually active.
5) Ability to comply with the entire study procedures, ability to communicate
meaningfully with the investigational staff, competence to give written informed
consent; to be applied to the parents and/or patients, as appropriate
6)Duly executed, written, informed consent obtained from the parents or other legal
representative and/or the patient according to requirement of the local ethics committee.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Treatment with the CYC, AZA or mycophenolate mofetil anytime before randomisation.
2) Neutrophil count <1,500 cell/mm3 and/or platelet count <50,000/mm3.
3) History of poor compliance with previous treatment.
4) Evidence of current use of alcohol or illicit drugs abuse.
5) Live vaccines not allowed during the entire duration of the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effectiveness (efficacy, safety, tolerability and compliance to<br>treatment) of 3 CYC regimens for the treatment of children with JSLE biopsy proven<br>proliferative lupus glomerulonephritis (revised version of the World Health Organisation [WHO] class III, IV);Secondary Objective: THE OVERALL HYPOTHESIS TO BE TESTED IN THIS<br>JSLE TRIAL is to find out the relative effectiveness of 3 therapeutic schemes, i.e. the lowest<br>effective and safest dose, and the shortest duration of treatment with CYC for the prevention of<br>renal relapses while avoiding gonadal toxicity.;Primary end point(s): To assess the effectiveness (efficacy, safety, tolerability and compliance to<br>treatment) of 3 CYC regimens for the treatment of children with JSLE biopsy proven<br>proliferative lupus glomerulonephritis (revised version of the World Health Organisation [WHO] class III, IV)