A Controlled Randomized Open-label Multicenter Study Evaluating if Early Conversion to Everolimus (Certican) From Cyclosporine (Neoral) in de Novo Renal Transplant Recipients Can Improve Long-term Renal Function and Slow Down the Progression of Chronic Allograft Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Measured Glomerular Filtration Rate
研究概览
简要总结
This study is designed to evaluate if early conversion to everolimus from cyclosporine in de novo renal transplant recipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second single renal transplant from deceased or living donor
- •Exclusion criteria
- •Recipient of organs other than a renal transplant
- •Present malignancy (within the last 2 years) other than excised basal cell or squamous cell carcinoma of the skin
- •Severe liver disease
- •At the time of randomization 7 weeks after transplantation
- •In addition to the above criteria the following must be met at time of randomization:
- •Inclusion Criteria:
- •Patients maintained on a triple immunosuppressive regime consisting of cyclosporine, Enteric coated mycophenolate, and corticosteroids
- •Patients completed the first 7 weeks without experiencing any rejection
排除标准
- •Graft loss
- •Low hemoglobin value, low number of white blood cells or platelets
- •High cholesterol values
- •Proteinuria
- •Wound healing problems
- •Current severe major local or systemic infection
- •Renal insufficiency
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Everolimus (CNI-free)
Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart.
干预措施: everolimus (Drug)
Everolimus (CNI-free)
Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart.
干预措施: Enteric Coated Mycophenolate Sodium (EC-MPS) (Drug)
Everolimus (CNI-free)
Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart.
干预措施: corticosteroids (Drug)
Everolimus (CNI-free)
Patients in this group were converted to everolimus immunosuppressive therapy. The patients in the everolimus group were treated with everolimus, off-label (CNI-free) use, and EC-MPS and corticosteroids in accordance with local practice and approved label. Conversion to everolimus was as follows: Day 1: begin everolimus 3 mg in the evening. Usual morning dose of CsA and 50% reduced evening dose of CsA Day 2: everolimus 2 mg in the morning and 2 mg in the evening, complete discontinuation of CsA Day 3 or 4, and onwards: everolimus according to trough level 6-10 ng/mL.The given total daily dose of the immunosuppressive drugs (everolimus) was divided into two (equal) doses, applied 12 hours apart.
干预措施: Basiliximab (Drug)
Control (CsA)
Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart.
干预措施: cyclosporine A (Drug)
Control (CsA)
Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart.
干预措施: Enteric Coated Mycophenolate Sodium (EC-MPS) (Drug)
Control (CsA)
Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart.
干预措施: corticosteroids (Drug)
Control (CsA)
Patients in the control group continued on an immunosuppressive regimen. The patients in this Control group were treated with CsA, EC-MPS and corticosteroids in accordance with local practice and approved label. The given total daily dose of the immunosuppressive drugs (CsA and EC-MPS) was divided into two (equal) doses, applied 12 hours apart.
干预措施: Basiliximab (Drug)
结局指标
主要结局
Measured Glomerular Filtration Rate
时间窗: Month 12
To compare the efficacy between treatment regimens by assessing the difference in renal function evaluated by mean measured glomerular filtration rate (mGFR) 12 months after renal transplantation (TX). The mGFR was measured using Iohexol or Cr-EDTA clearance according to local practice.
次要结局
- Time to First Malignancy(Months 12, 24, 36)
- Percentage of Participants Who Developed CAN (Chronic Allograft Nephropathy)(Month 12, Month 36)
- Lipid Profile for Apolipoprotein(Months 12, 24, 36)
- Percentage of Participants Who Had Donor Specific Antibodies (DSA)(Month 36)
- Lipid Profile for HDL-C, LDL-C,Total Cholesterol, and Triglycerides(Months 12, 24, 36)
- Number of Antihypertensive Drugs Taken(Months 12, 24, 36)
- Proteinuria (Measured as Urine Albumin/Creatinine Ratio (mg/mmol))(Months 12, 24, 36)
- Health-related Quality of Life (QoL) as Measured by EuroQoL EQ-5D(Before randomization, Months 12, 36)
- Measured Glomerular Filtration Rate(Month 36)
- Percentage of Participants With Biopsy Proven Acute Rejection (BPAR)(Months 12, 24, 36)
- Percentage of Participants on Antihypertensive Drugs(Months 12, 24, 36)
- Percentage of Participants With Graft Loss or Death(Months 12, 24, 36)
- Percentage of Participants With Treatment Failures(Months 12, 24, 36)
- Calculated Glomerular Filtration Rate(Months 12, 36)
- Progression of Measured Glomerular Filtration Rate(Week 7, Week 52, Month 36)
- Time to Treatment Failure(Months 12, 24, 36)
- Number of Lipid-lowering Drugs Taken(Months 12, 24, 36)
- Percentage of Participants on Lipid-lowering Drugs(Months 12, 24, 36)