A 3-month, Multicenter, Randomized, Open Label Study to Evaluate the Impact of Early Versus Delayed Introduction of Everolimus on Wound Healing in de Novo Kidney Transplant Recipients With a Follow-up Evaluation at 12 Month After Transplant (NEVERWOUND Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 383
- 试验地点
- 1
- 主要终点
- Percentage of Participants Without Wound Healing Complications - Worst-case Scenario
研究概览
简要总结
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate administration in de novo renal transplant patients (proportion of patients without wound/surgical complications related to initial transplant surgery) between randomization and 3 months after transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Immediate Everolimus (IE)
Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
干预措施: Everolimus (Drug)
Immediate Everolimus (IE)
Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
干预措施: Cyclosporine (Drug)
Immediate Everolimus (IE)
Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
干预措施: Steroids (Drug)
Delayed Everolimus
The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
干预措施: Everolimus (Drug)
Delayed Everolimus
The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
干预措施: Mycophenolate sodium (Drug)
Delayed Everolimus
The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
干预措施: Cyclosporine (Drug)
Delayed Everolimus
The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
干预措施: Steroids (Drug)
结局指标
主要结局
Percentage of Participants Without Wound Healing Complications - Worst-case Scenario
时间窗: 3 months
The percentage of participants without wound healing complications was assessed. Wound healing complications consisted of lymphorrhea, fluid collections, wound dehiscence, wound infections and incisional hernia. In the worst-case scenario, failure, i.e. at least one healing complication occurrence, was identified in one of the following cases: wound complication occurrence, missing information about wound complication occurrence, or study discontinuation due to any reason.
次要结局
- Change From Baseline in Serum Creatinine - Modified ITT(baseline, 12 months)
- Percentage of Participants With Proteinuria(3 months)
- Percentage of Participants With Acute Rejection (AR)(12 months)
- Percentage of Participants With a New Onset of Malignancy(12 months)
- Percentage of Participants With a New Onset of Diabetes(12 months)
- Percentage of Participants Without Wound Healing Complications - Worst-case Scenario(12 months)
- Percentage of Participants Who Experienced Treatment Failure - Worst-case Scenario(3 months)
- Patient Survival Rate: Percentage of Deaths - Worst-case Scenario(3 Months, 12 months)
- Participant/Graft Survival Rate: Percentage of Participants With Failure Events of Death or Graft Loss - Worst-case Scenario(3 months)
- Graft Survival Rate: Percentage of Participants With Graft Loss - Worst-case Scenario(3 months, 12 months)
- Percentage of Participants With BPAR - Worst-case Scenario(3 Months, 12 months)
- Percentage of Participants With Delayed Graft Function (DGF) -(3 Months)
- Duration of DGF(3 months)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - ITT(baseline, 3 Months)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) (Calculated With Modified Diet in Renal Disease (MDRD)-4 Formula - Modified ITT(baseline, 12 months)
- Change From Baseline in Serum Creatinine - ITT(baseline, 3 months)