跳至主要内容
临床试验/NCT04945785
NCT04945785进行中(未招募)不适用

" SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients"

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 226 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
226
试验地点
1
主要终点
Improvement of kidney allograft between month 1 and month 12

研究概览

简要总结

The use of calcineurin inhibitors (CNIs) in kidney transplantation is the gold standard treatment to prevent episodes of rejection. Nevertheless, CNIs have side effects and are in particular nephrotoxic for the kidney transplant. Monitoring CNI dosages is fundamental for the clinician, in order to find the right balance between toxicity and prevention of rejection. Several recent studies suggest that a Radio Residual Concentration / Dosage (C0 / D) less than 1.05 (patients with rapid metabolizers) is associated with poor graft function (eGFR) and decreased kidney transplant survival. LCPT prolonged-release tacrolimus (Novel Once-Daily Extended-Release Tacrolimus. Prolonged-release tacrolimus: Envarsus®) is a marketed form of tacrolimus with interesting pharmacokinetic properties: daily intake, reduction of the absorption peak (Meltodose® technology ) and reduction of the total CNI dose by 30% to obtain an equivalent CO compared to other molecules on the market (Advagraf®, Prograf®). Thus, the use of LCPT in patients rapid metabolisers in relay of Advagraf® or Prograf® could make it possible to decrease renal toxicity while preserving rejection, by increasing the C0 / D ratio.

The investigators propose a pilot study aiming to study a prospective cohort of rapid metabolisers patients put on Envarsus at one month of transplant compared to a historical cohort, in terms of C0 / D ratio, function and survival of the renal graft.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient ≥ 18 years old
  • 1st or 2nd kidney transplant
  • Transplantation from a deceased donor (Encephalic death or arrested heart Maastricht III) or living donor
  • C0 / D ratio <1.05 at one month of kidney transplant
  • Renal graft function <60ml / min (eGFR estimate by CKD-EPI or MDRD).

排除标准

  • Patient ≤ 18 years old, under guardianship or protected
  • Graft rank ≥ 3
  • Renal graft function <30 ml / min (eGFR estimate by CKD-EPI or MDRD)
  • Presence of pre-transplant DSA (threshold> 2000 MFI)
  • Occurrence of histologically proven rejection during the 1st month of transplant
  • Presence of another functional transplant (heart / lung / liver / pancreas) or kidney bi-transplant
  • Transplantation from a living donor
  • Transplantation from an arrested heart donor Maastricht II

结局指标

主要结局

Improvement of kidney allograft between month 1 and month 12

时间窗: 12 months

comparison of eGFR (estimated Glomerular Filtration Rate) level at M12 by using the MDRD formula between Envarsus® and Advagraf® groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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