NCT02314312Unknown3 期
A 12 Month, Single-center, Open-label, Randomized-controlled Trial to Investigate Efficacy, Safety and Tolerability of Everolimus in Combination With Cyclosporine A and Corticosteroid in de Novo Transplant Recipients of Expanded Criteria Donor Kidneys or Acute Kidney Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 48
- 主要终点
- eGFR (CKD-EPI)
研究概览
简要总结
Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation
详细描述
Secondary Endpoints:
- To assess renal function by means of eGFR (Cockcrault and Gault formula), at -Month 6 and 12 post-transplantation
- To assess incidence of the individual composite endpoints including BPAR, graft loss and death at Month 6 and 12 post-transplantation
- To assess the incidence and duration of renal replacement therapy
- To assess the incidence of chronic allograft nephropathy (IF/TA) at Month 12
- To assess renal function by means of serum creatinine at Month 6 and 12 post-transplantation
- To compare the overall safety and tolerability (incidence of AEs and SAEs, infections, discontinuations due to AEs, lab abnormalities, wound and surgical complications) at Month 6 and 12 post-transplantation
Definition of ECD
- Brain-dead donor > 60 years old or
- Donor age > 50 years old with two of the following criteria;
- History of HT
- Terminal SCr. ≥ 1.5 mg/dL
- Death from cerebrovascular accident Definition of AKI donor
- Brain-dead donor with an increase of SCr. ≥ 0.3 mg/dL from baseline
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Recipients of first DDKT from ECD or AKI donors
- •Patient willing to participate in the study
排除标准
- •Multi-organ recipients
- •Organ donation after Cardiac Death (DCD).
- •PRA > 20 % or with historical peak PRA > 50%
- •Patients who lost first graft due to immunological reason within the first year post-transplantation.
- •ABO incompatible transplants or positive cross-match
- •Patients with chronic inflammatory bowel disease.
- •Severe allergy requiring acute treatment, or any known hypersensitivity to everolimus, thymoglobulin
- •Thrombocytopenia (platelet < 75,000/mm3), ANC < 1,500 /mm3 or leucopenia (leucocytes < 2,500/mm3), or Hb < 6 g/dL
- •Chronic active HCV, HIV, or HBsAg positive
- •History of malignancy during the last five years, except squamous or basal cell carcinoma of the skin.
- •Ongoing infection requiring treatment with a systemic antibiotic.
- •Patient with severe hypercholesterolemia (> 300 mg/dL) or hypertriglyceridemia (> 600 mg/dL) that cannot be controlled
- •Evidence of severe liver disease.
- •Severe restrictive or obstructive pulmonary disorders.
- •Pregnant or nursing (lactating) women.
- •Patient who refuse to participate into the study or would like to withdraw from the study.
研究组 & 干预措施
B: control arm
Other
De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen
干预措施: Standard immunosupressive regimen (Drug)
A: investigation arm
Experimental
De novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen
干预措施: Everolimus + low dose cyclosporin A + prednisolone (Drug)
结局指标
主要结局
eGFR (CKD-EPI)
时间窗: 12 months post kidney transplantation
次要结局
未报告次要终点
研究者
CHALERMPON NA PETVICHARN
Ramathibodi Hospital
Mahidol University
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