NCT00140543已完成3 期
A European Multicenter Open-Label Randomised Trial to Evaluate the Efficacy and Safety of Sirolimus and Tacrolimus Compared to MMF and Tacrolimus With Short-Course Induction Therapy, Short-Term Steroids Application in de Novo SPK Transplanted Diabetic Patients
EUROSPK Study Group28 个研究点 分布在 7 个国家目标入组 228 人开始时间: 2002年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 28
- 主要终点
- At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.
研究概览
简要总结
- To determine and compare the efficacy of Tacrolimus/Rapa versus Tacrolimus/MMF-based immunosuppression (in conjunction with initial short-term steroids and polyclonal antibody administration) in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation.
- To evaluate the safety of Tacrolimus/Rapa versus Tacrolimus/MMF in terms of drug-related complications and overimmunosuppression-associated complications, particularly under monitoring of the pharmacokinetic profile of all drugs administered.
详细描述
This will be a controlled, randomised study, to be performed in 15-20 pancreas transplantation centers throughout Europe. Patients will be randomised into one of two treatment groups. Group 1 will receive Tacrolimus and Mycophenolate Mofetil (= best group in EuroSPK001 trial). Group 2 will receive Tacrolimus and Sirolimus. Both groups will receive in association short-term corticosteroids and polyclonal antibody preparation. Patients will be randomly assigned to one of the 2 treatment groups in a 1:1 ratio before transplantation. The study will last 3 years, with a first interim analysis of the data at 6 months and a complete analysis at 1 year.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, of 18 to 55 years of age, with end-stage, C-peptide-negative, Type 1-diabetic nephropathy.
- •Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (3 years).
- •Patient must have signed the Patient Informed Consent Form.
- •Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
排除标准
- •Patient is pregnant or breastfeeding.
- •Patient is allergic or intolerant to Mycophenolate Mofetil, Sirolimus, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
- •Patient has a positive T-cell crossmatch on the most recent serum specimen.
- •Patient is known for active liver disease or has significant liver disease, defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
- •Patient has malignancy or history of malignancy, with the exception of adequately treated localised squamous cell or basal cell carcinoma, without recurrence.
- •Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomisation.
- •Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
- •Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
- •Pancreatic duct occlusion technique .
- •Donor is older than 55 years of age.
结局指标
主要结局
At 1 year:Incidence of biopsy-proven (kidney) rejection episodes.
次要结局
- * Kidney/Pancreas function (at 6 months and 1 year):
- SECONDARY ENDPOINTS: At 6 months and 1 year
- - Kidney function will be measured by:
- - S- creatinine
- - Creatinine clearance
- - Pancreas function will be measured by:
- - Fasting Glucose level (< 123 mg/dl)
- - HbA1C
- - Need for insulin therapy
- - Need for oral drugs
- * At 6 months and 1 year:
- - Patient and graft survival
- - Lipid profile
- - Infections
- - Side effects
- - Blood Pressure
- - Treatment failure for any reason, such as permanent discontinuation of a drug, graft loss or death.
- * % of steroid free patients: at 6 months and 1 year.
研究者
研究点 (28)
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