Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Change in estimated glomerular filtration rate (eGFR)
研究概览
简要总结
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Everolimus (Drug)
结局指标
主要结局
Change in estimated glomerular filtration rate (eGFR)
时间窗: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
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).
次要结局
- graft acute rejection(6 and 12 months after conversion)
- Laboratory results and clinical alterations(3, 6 and 12 months after conversion)
研究者
Helady Pinheiro, MD, PhD
MD, PhD
Fundação Instituto Mineiro de Estudo Pesquisa Em Nefrologi