Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 9
- 主要终点
- Tolerance of the Certican®-Envarsus® association
研究概览
简要总结
The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage.
The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack of information justify a modality of use and tolerence evaluation of this new association, commonly used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Patients informed and giving his agreement to the use of every collected data
- •Patients with kidney transplantation for at least one year and being treated with the immunosppressive assiociation of Tacrolimus (Prograf ®)-Everolimus
- •Patients whose investigators decides to switch from Prograf ® to an Envarsus ®-Everolimus association
排除标准
- •Other transplantation
- •Drug or alcohol abuse
- •Patients unable to understand the purpose or modalities of this study, unable to give his agreement or unable to stick to the protocol
- •Patients on an interventionnal protocol when included
结局指标
主要结局
Tolerance of the Certican®-Envarsus® association
时间窗: During 1 year, between each visit (J0, M3, M6, M9, M12)
Assess clinical and biological tolerance of the Certican®-Envarsus® association on kidney transplanted patient, one year after transplant : study of adverse events with biological results (biochimy, hematology). Study of incidence of Treatment-Emergent Adverse Events.
次要结局
- Treatment(1 year)
- Renal function(1 year)
- Medication compliance(1 year)
- Graft Rejections and survival rates(1 year)
- Patients description(1 year)
- clinical evolution(1 year)