NCT02036554Unknown4 期
To Evaluate Prevention Effect Of Everolimus and Low-dose Tacrolimus in Comparison With Standard-dose Tacrolimus Therapy With Mycophenolic Acid on the New Onset Diabetes Mellitus After Transplantation in the Renal Allograft Recipients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Change from Baseline in Development of NODAT (Fasting glucose ≥ 126 mg/dL, Random glucose ≥ 200 mg/dL) at 12 months
研究概览
简要总结
To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation in the renal allograft recipients
详细描述
An open-label, randomized, multi-center, comparative parallel study to evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation in the renal allograft recipients: PROTECT study
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 year old
- •At least 3 months after kidney transplantation
- •Subject who is using Tacrolimus ± purine synthesis inhibitor + steroid without change within the past 3 months (except the dosage)
- •MDRD eGFR ≥ 50 mL/min or serum creatinine < 2.0mg/dL within the past 3 months in the 6months after kidney transplantation
- •Rate of change of serum creatinine < +30% within the past 3 months in the 6months after kidney transplantation (if serum creatinine decreased, without rate of change is inclusion possible. if serum creatinine result was normal,regardless of the rate of change is able to register.)
- •Urine protein/creatinine ratio < 1g/g Cr (spot urine) Subject who is not applicable to the diagnostic criteria NODAT on
- •the baseline in the 6months after kidney transplantation
- •Subjects who agree with written informed consent
排除标准
- •Subjects who received combined non-renal transplantation
- •Subject who received re-transplantation
- •ABO blood group incompatible(when anti-ABO Antibody titer <1:128 is inclusion possible.)
- •Sensitized patients before transplantation
- •Pretransplant or peak PRA titer > 50%
- •Pretransplant T cell cytotoxicity crossmatch (+)
- •HLA-identical living related donor
- •Subject who has diabetes mellitus / NODAT before transplantation
- •Subject who has suffered acute rejection episode within the past 3 months in the 6months after kidney transplantation
- •Subject with hypersensitivity to everolimus
- •Subject who should continue nephrotoxic drug until enrollment (Aminoglycoside, amphotericin B, cisplatin)
- •Subject with GI disorder that might interfere with the ability to absorb oral medication. (eg, gastrectomy or insufficiently treated diabetic gastroenteropathy)
- •Subjects with active peptic ulcer
- •HIV, HBsAg, or HCV Ab tests (+)
- •Abnormal liver function test (AST or ALT or total bilirubin> upper normal limit x3)
- •ANC <1.5*109/L or WBC <2.5*109/L or platelet <75*109/L
- •Treatment with an investigational drug within 30 days preceding the first dose of trial medication
- •Women who are either pregnant, lactating, planning to become pregnant in the next 12 months.
- •Subjects with history of cancer(except successfully treated), localized nonmelanocytic skin cancer, PTLD(Post-transplant lymphoproliferative disorder)
- •Subjects with clinically significant infections within the past 4 weeks in the 6months after kidney transplantation
- •Subjects who took major surgery within the past 4 weeks in the 6months after kidney transplantation
研究组 & 干预措施
Tacrolimus plus Everolimus
Experimental
Low dose Tacrolimus + Everolimus
干预措施: Everolimus (Drug)
Tacrolimus plus Everolimus
Experimental
Low dose Tacrolimus + Everolimus
干预措施: Tacrolimus (Drug)
Tacrolimus plus Mycophenolic acid
Active Comparator
standard dose Tacrolimus + Mycophenolic acid
干预措施: Tacrolimus (Drug)
Tacrolimus plus Mycophenolic acid
Active Comparator
standard dose Tacrolimus + Mycophenolic acid
干预措施: Mycophenolic acid (Drug)
结局指标
主要结局
Change from Baseline in Development of NODAT (Fasting glucose ≥ 126 mg/dL, Random glucose ≥ 200 mg/dL) at 12 months
时间窗: 0 to 12 month
To evaluate prevention effect of combination therapy of Everolimus and low-dose Tacrolimus in comparison with standard-dose Tacrolimus therapy with Mycophenolic acid on the New Onset Diabetes Mellitus after transplantation at 12 months after date of randomization.
次要结局
- Number of hospitalization of any cause (except admission for protocol biopsy) at 12 month(V6)(at 12 month(V6))
- Creatinine clearance (MDRD eGFR) at 9 month(V5)(at 9 month(V5))
- Needs for anti-diabetic medication or insulin at 9 month(V5)(at 9 month(V5))
- Creatinine clearance (MDRD eGFR) at Baseline(V2)(at Baseline(V2))
- Insulin secretion by HOMA-beta(0 to 12 months)
- OGTT (Fasting and PP2hr)(0 to 12 months)
- Creatinine clearance (MDRD eGFR) at 6 month(V4)(at 6 month(V4))
- 12 month graft survival(at 12 months(V6))
- Proportion of patients with significant proteinuria greater than 1g/gCr at 6 month(V4)(at 6 month(V4))
- Proportion of patients with significant proteinuria greater than 1g/gCr at 12 month(V6)(at 12 month(V6))
- Number of hospitalization of any cause (except admission for protocol biopsy) at 9 month(V5)(at 9 month(V5))
- Needs for anti-diabetic medication or insulin at 3 month(V3)(at 3 month(V3))
- Needs for anti-diabetic medication or insulin at 6 month(V4)(at 6 month(V4))
- Proportion of patients with significant proteinuria greater than 1g/gCr at 9 month(V5)(at 9 month(V5))
- Number of hospitalization of any cause (except admission for protocol biopsy) at Baseline(V2)(at Baseline(V2))
- Number of opportunistic infections (BKVN) at Baseline(V2)(at Baseline(V2))
- Prevalence of NODAT at 3 month(V3)(at 3 month(V3))
- Needs for anti-diabetic medication or insulin(at Baseline(V2))
- Needs for anti-diabetic medication or insulin at 12 month(V6)(at 12 month(V6))
- Proportion of patients with significant proteinuria greater than 1g/gCr at Baseline(V2)(at Baseline(V2))
- Proportion of patients with significant proteinuria greater than 1g/gCr at 3 month(V3)(at 3 month(V3))
- Number of hospitalization of any cause (except admission for protocol biopsy) at 3 month(V3)(at 3 month(V3))
- Number of hospitalization of any cause (except admission for protocol biopsy) at 6 month(V4)(at 6 month(V4))
- Number of opportunistic infections (BKVN) at 12month(V6)(at 12 month(V6))
- Prevalence of NODAT at 9 month (V5)(at 9 month (V5))
- Insulin resistance by HOMA-IR(0 to 12 months)
- Creatinine clearance (MDRD eGFR) at 3 month(V3)(at 3 month(V3))
- Creatinine clearance (MDRD eGFR) at 12 month(V6)(at 12 month(V6))
- 12 month patient survival rate(at 12 months(V6))
- Change from baseline in Microalbuminuria(MAU) at 12 months(at 12 months(V6))
- Number of episode of biopsy proven acute rejection (BPAR)(at 12 month(V6))
- Prevalence of NODAT at Baseline(V2)(at Baseline(V2))
- Prevalence of NODAT at 6 month(V4)(at 6 month(V4))
- Prevalence of NODAT at 12 month(V6)(at 12 month(V6))
研究者
ChulWoo Yang
Professor
Seoul St. Mary's Hospital
研究点 (1)
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