ISRCTN16948923进行中（未招募）3 期
A randomised, two-arm (1:1 ratio), double blind, placebo controlled phase III trial to assess the efficacy, safety, cost and cost-effectiveness of rituximab in treating de novo or relapsing NS in patients with MCD/FSGS (TURING)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age 16 years or older.
- •2. NS at trial entry (serum albumin < 35g/l and protein creatinine ratio (PCR) > 300mg/mmol) secondary to MCD/FSGS with,
- •3. De novo disease or relapsing disease in a patient previously steroid or calcineurin inhibitor (CNI) responsive.
- •4. Latest biopsy (at any time) proven MCD/FSGS.
- •5. Ability to provide written informed consent.
- •6. Agreed to be enrolled in the National Registry of Rare Kidney Disease (RaDaR).
排除标准
- •1. MCD or FSGS due to secondary causes, including obesity-driven hyperfiltration, remnant kidneys, malignancy of a type likely to be associated with MCD /FSGS and genetic polymorphisms known to be associated with nephrosis
- •2. MCD/FSGS secondary to malignancy, including lymphoproliferative disorders
- •3. Family history of MCD or FSGS in a first degree relative
- •4. Previous rituximab within 18 months preceding Day 0 (SPPR), or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets
- •5. Previous cyclophosphamide within 6 months preceding Day 0 (SPPR)
- •6. Prednisolone daily dose equal to or greater than 60mg, with a course length of greater than4 weeks, immediately prior to randomisation
- •7. Evidence of current or past infection with Hepatitis B, C or HIV (unless appropriate prophylaxis is given and no replicating virus is detected)
- •8. Positive serum pregnancy test (within 14 days prior to treatment with IMP in main trial and rituximab in OLP)
- •9. Evidence of active severe infection
- •10. Severe heart failure or severe, uncontrolled cardiac disease
- •11. Pregnant or breast-feeding women
- •12. Live vaccine administration in the four weeks prior to enrolment and while remaining on IMP treatment
- •13. Previous/known hypersensitivity to prednisolone or IMP or to murine proteins (and any excipients as described in section 6.1 of the SmPC)
- •14. Co-enrolment in another clinical trial of an investigational medicinal product
- •15. Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial
- •16. An increase in CNI dose in the four weeks preceding randomisation
研究者
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