Study of Everolimus in de Novo Renal Transplant Recipients
Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes.
The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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MG
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Divinópolis、MG、巴西、35500-227
- Hospital São João de Deus/Fundação Geraldo Corrêa
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Ipatinga、MG、巴西、35160-158
- Hospital Márcio Cunha/Fundação São Francisco Xavier
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Juiz de Fora、MG、巴西、36036-330
- Fundação IMEPEN
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Montes Claros、MG、巴西、39400-103
- Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Renal transplant patients
- Age between 18 and 85 years
- Recipients of living or deceased donors
- Donor under the age of 85 years
- Panel Reactivity Antibodies (PRA) over or equal to 30%
- 4-5 months post-transplant
- CNI-based immunosuppressive regimen
- Stable graft function (creatinine lower than 2.0 mg/dl)
- No currently acute rejection
- Proteinuria lower than 800mg/d
- No laboratory or physical clinically significant signs presented for the last 2 months before screening.
Exclusion Criteria:
- Recipient of multiple organs
- Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis
- Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL)
- Patients with eGFR lower than 40 ml/min/1.73m2
- Evidence of acute rejection within 2 months before screening
- Thrombocytopenia (lower than 75,000/mm3)
- Neutropenia (lower than 1,500/mm3)
- Leukocytopenia (lower than 2500/mm3)
- Anemia (hemoglobin lower than 6.0g/dL)
- Severe liver disease (including transaminases or bilirubin equal or over 3 times normal)
- Proteinuria over 800mg/dL
- Systemic infection or pneumonia (active infection)
- Positive for Hepatitis B, Hepatitis C or HIV.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Control
35 patients using Cyclosporin or Tacrolimus (C0=100-200/5-10ng/mL)+ Myfortic® 1440mg/dia + Steroids. Medications will be administered orally, twice a day |
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有源比较器：Intervention
35 randomized Patients Converted to Certican® (Everolimus C0=6-10 ng/mL) + Myfortic® 1440mg/day + Steroids. On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended. |
On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in estimated glomerular filtration rate (eGFR)
大体时间：4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
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The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC).
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4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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graft acute rejection
大体时间：6 and 12 months after conversion
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incidence of acute biopsy-proven rejection and clinical acute rejection (without biopsy), graft loss, death with a functioning graft, and loss of follow up at 6 and 12 months after conversion;
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6 and 12 months after conversion
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Laboratory results and clinical alterations
大体时间：3, 6 and 12 months after conversion
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analyzing the incidence of anemia, thrombocytopenia, leukopenia, gastrointestinal side effects, pneumonitis, oral ulcers, edema, proteinuria, and any other adverse events, as well as the need of drug withdrawal
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3, 6 and 12 months after conversion
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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