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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT00336414
Date of registration: 12/06/2006
Prospective Registration: Yes
Primary sponsor: Istituto Giannina Gaslini
Public title: Five-Year Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis
Scientific title: Five-Year Single-Blind, Phase III Effectiveness Randomised Actively Controlled Clinical Trial in New Onset Juvenile Systemic Lupus Erythematosus Nephritis: Oral Cyclophosphamide Versus High Dose Intravenous Cyclophosphamide Versus Intermediate Dose Intravenous Cyclophosphamide
Date of first enrolment: June 2006
Target sample size: 0
Recruitment status: Withdrawn
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single.  
Phase:  Phase 3
Countries of recruitment
Name:     Nicolino Ruperto, MD, MPH
Affiliation:  Istituto Giannina Gaslini-PRINTO
Key inclusion & exclusion criteria

Inclusion Criteria:

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.

Diagnosis of JSLE according to the ACR revised classification criteria (57); Age at
enrolment = 18 years. 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

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 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.

Exclusion Criteria:

Treatment with the CYC, AZA or mycophenolate mofetil anytime before randomisation.

Neutrophil count <1,500 cell/mm3 and/or platelet count <50,000/mm3. History of poor
compliance with previous treatment. Evidence of current use of alcohol or illicit drugs
abuse. Live vaccines not allowed during the entire duration of the trial.

Age minimum: 1 Year
Age maximum: 18 Years
Gender: All
Health Condition(s) or Problem(s) studied
Systemic Lupus Erythematosus Nephritis
Drug: cyclophosphamide-prednisone-azathioprine
Primary Outcome(s)
core set variables:
health-related quality of life assessment.
physician's global assessment of disease activity on a 10 cm visual analogue scale; global disease activity measure by the mean of the European Consensus Lupus Activity parent's/patient's global assessment of overall well-being on a 10 cm VAS;
Primary: 50% improvement in at least 2 core set variables with no more tha 1 of the remaining variables worsened by> 30%
Secondary Outcome(s)
Change over time in the individual components of the JSLE
core set of variables; time to proteinuria disappearance; frequency of drop-out from
suggested steroids use; frequency of drop-out for inefficacy of treatment.
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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