BELASBRIDGE : Belatacept as a replacement for CNIs 3 to 12 months post-transplantation in patients with early graft dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- The feasibility of reintroduction of CNIs will be defined by preserved renal function and good tolerance at 6 months post reintroduction (15 months follow-up). Renal function will be defined as preserved if creatinine clearance (according to CKD-EPI) does not decrease by more than 25% after discontinuation of belatacept. Good tolerance of the reinstatement of CNIs will be defined by the absence of complications leading to discontinuation of the treatment.
研究概览
简要总结
To study the feasibility of transient (9 months, 3-12 months post-transplant) replacement of CNIs with belatacept in renal transplant patients with early graft dysfunction.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Overall trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Adult over 18 years of age.
- •Have no difficulty understanding and communicating with the investigator and his representatives
- •Affiliated with French social security system or beneficiary from such system
- •Transplantation from a deceased or living donor kidney (non-HLA-identical) with ABO compatibility
- •No contraindication to graft biopsy at 10 weeks post-transplant.
- •Maintenance treatment with CNI/MPA +/- prednisone
- •Renal function estimated by CKD-EPI creatinine clearance < 30 ml/min/1.73m
- •Willing to give written informed consent after information.
- •Results of the 10-week post-transplant renal biopsy showing no rejection or BK virus nephropathy, no recurrence of the initial disease, no thrombotic microangiopathy and no cortical necrosis.
- •EBV seropositivity
- •Negative pregnancy test for patients of childbearing age, and agreement to use effective contraception throughout the study
排除标准
- •Presence of DSA at the time of renal transplantation or at 3 months post-transplant.
- •Positive HIV serology.
- •History of other solid organ transplantation (other than kidney)
- •Primary non-function (still needing for dialysis at 3 months post-transplant).
- •Ongoing participation in another clinical trial
- •Any clinical condition that the investigator considers incompatible with the safe conduct of the trial (in particular active infection, active cardiovascular complication, active neoplastic disease)
- •Contraindication to Belatacept (referring to the SmPC).
- •Pregnant or breastfeeding woman
- •Person under guardianship or curatorship, under court protection
结局指标
主要结局
The feasibility of reintroduction of CNIs will be defined by preserved renal function and good tolerance at 6 months post reintroduction (15 months follow-up). Renal function will be defined as preserved if creatinine clearance (according to CKD-EPI) does not decrease by more than 25% after discontinuation of belatacept. Good tolerance of the reinstatement of CNIs will be defined by the absence of complications leading to discontinuation of the treatment.
The feasibility of reintroduction of CNIs will be defined by preserved renal function and good tolerance at 6 months post reintroduction (15 months follow-up). Renal function will be defined as preserved if creatinine clearance (according to CKD-EPI) does not decrease by more than 25% after discontinuation of belatacept. Good tolerance of the reinstatement of CNIs will be defined by the absence of complications leading to discontinuation of the treatment.
次要结局
- Longitudinal monitoring of renal function (M0, M3, M6, M9), collection of rejection events.
- Collection of infectious episodes and neoplasia.
- Number of care resources consumed in relation to treatments (drugs, hospitalisation, transport, consultations, biological procedures, medical procedures, possible home help) and associated costs over 15 months of follow-up, and collection of cost data from the literature for comparison.
- Measurement of quality of life scores (generic EQ-5D scale) every 3 months for 15 months and collection of quality of life data from the literature for comparison.
- Differential analysis (before and after belatacept discontinuation) of cell populations by standardised flow cytometry combined with unbiased analysis.
- Differential analysis (before and after belatacept discontinuation) of the anti-CMV cellular immune response.
研究者
Simon VILLE
Scientific
Centre Hospitalier Universitaire De Nantes