EUCTR2005-003957-28-BE进行中（未招募）1 期
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 - PRINTO JSLE Trial
niversity Hospital Gent0 个研究点目标入组 216 人开始时间: 2006年10月24日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria. Each patient must meet all the following 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
排除标准
- •Exclusion Criteria. Any of the following will exclude a patient from this trial:
- •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.
研究者
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