EUCTR2018-004611-50-GB进行中（未招募）1 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) - TURING
适应症
试验速览
- 阶段
- 1 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 clinical trial of medicinal product
入排标准
入选标准
- •To be included in the trial the participant must:
- •Age 16 years or older.
- •NS at trial entry (serum albumin < 35g/l and protein creatinine ratio (PCR) >300mg/mmol) secondary to MCD/FSGS with,
- •De novo disease or relapsing disease in a patient previously steroid or calcineurin inhibitor (CNI) responsive.
- •Latest biopsy (at any time) proven MCD/FSGS.
- •Ability to provide written informed consent.
- •Agreed to be enrolled in the National Registry of Rare Kidney Disease (RaDaR).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 5
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 72
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •The presence of any of the following will preclude participant inclusion:
- •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
- •MCD/FSGS secondary to malignancy, including lymphoproliferative disorders
- •Family history of MCD or FSGS in a first degree relative
- •Previous rituximab within 18 months preceding Day 0 (SPPR), or 12 months if there is evidence of B cell return in peripheral lymphocyte subsets
- •Previous cyclophosphamide within 6 months preceding Day 0 (SPPR)
- •Prednisolone daily dose equal to or greater than 60mg, with a course length of greater than4 weeks, immediately prior to randomisation
- •Evidence of current or past infection with Hepatitis B, C or HIV (unless appropriate prophylaxis is given and no replicating virus is detected).
- •Positive serum pregnancy test (within 14 days prior to treatment with IMP in main trial and rituximab in OLP)
- •Evidence of active severe infection
- •Severe heart failure or severe, uncontrolled cardiac disease
- •Pregnant or breast-feeding women
- •Live vaccine administration in the four weeks prior to enrolment and while remaining on IMP treatment
- •Previous/known hypersensitivity to prednisolone or IMP or to murine proteins (and any excipients as described in section 6.1 of the SmPC).
- •Co-enrolment in another clinical trial of an investigational medicinal product
- •Any other reason which, in the opinion of the Principal Investigator (PI), renders the patient unsuitable for the trial.
- •An increase in CNI dose in the four weeks preceding randomisation
研究者
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