NCT01195194已完成4 期
Pilot Study of Selection of Either Calcineurin Inhibitor(CNI)-Based or CNI-free Immunosuppressive Regimen Depending on the Result of Pre-transplantation Donor-specific T-cell Reactivity Measured by Enzyme-linked Immunosorbent Spot(ELISPOT) in Standard-risk Kidney Recipients.
Josep M Grinyo2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Percentage of biopsy-confirmed acute rejection episodes
研究概览
简要总结
The objective is to assess if low pre-transplantation donor specific T-cell reactive patients measured by Enzyme-linked immunosorbent spot (ELISPOT)assay can be safely managed with Calcineurin inhibitor(CNI)-free Sirolimus(SRL)-based immunosuppression.
详细描述
Non randomized, pilot, prospective, open-label trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of donor and recipient between 18 and 65 years.
- •End-stage renal disease and scheduled to receive a primary or secondary renal allograft from a cadaveric, a living-unrelated, or a living-related donor. Patients scheduled for a second transplant must have maintained their primary graft for at least 6 months after transplantation, with the exception of graft failure due to technical reasons.
- •Panel reactive antibody (PRA) ≤ 20%, with negative standard cross-match.
- •Women of childbearing potential must have a negative serum pregnancy test before randomization.
- •Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.
- •Signed and dated informed consent prior to transplantation.
排除标准
- •Multiple organ transplants
- •Recipients of adult or pediatric en bloc kidney transplants or dual transplantation or non-heart beating donors.
- •Evidence of active systemic or localized major infection.
- •Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during the screening/baseline evaluation.
- •Use of any investigational drug or treatment up to 4 weeks prior to transplantation.
- •Treatment with voriconazole, ketoconazole, itraconazole, fluconazole, clotrimazole, astemizole, pimozide, terfenadine, erythromycin, clarithromycin, telithromycin, troleandomycin, rifampin, rifabutin, or St. John's Wort that is not discontinued prior to randomization.
- •Treatment with aminoglycosides, amphotericin B, cisplatin, cisapride, metoclopramide, cimetidine, bromocriptine, danazol, or other drugs associated with renal dysfunction that are not discontinued prior to randomization.
- •Subjects with a screening/baseline total white blood cell count < 2,000/mm3 or absolute neutrophil count (ANC) < 500, platelet count < 100,000/mm
- •Fasting triglycerides > 400 mg/dL (> 4.6 mmol/L) or fasting total cholesterol > 300 mg/dL (> 7.8 mmol/L) despite optimal lipid-lowering therapy.
- •History of malignancy within 2 years of enrollment (except for adequately treated basal cell or squamous cell carcinoma of the skin).
- •Auto-immune diseases inactive immunosuppressive treatment ( 3 months prior to inclusion).
- •Patient with psychiatric disorders that could be non-compliance for the treatment.
- •Non Caucasian patients.
- •Active peptic ulcers that could produce intestinal absorption disorders.
- •Subjects who are known to be human immunodeficiency virus(HIV) or hepatitis B virus (HBV) positive. Patients with hepatitis C virus (HCV) positive should be excluded if polymerase chain reaction (PCR) positive or transaminates values are ≥2 upper normal value (UNV).
- •Diabetic patients.
- •Body mass index higher than 30 Kg/m2.
研究组 & 干预措施
A- negative pre-transplant ELISPOT
Experimental
Sirolimus: Start at 5 mg/day as soon as treatment allocation arrives to obtain targeting levels to 8 -15 ng/ml (immunoassay) in the first 3 months, followed by trough levels of 5-10 ng/ml.
干预措施: PRE-TRANSPLANT (PRE=before) (Drug)
B- Positive pre-transplant ELISPOT
Experimental
Tacrolimus 0.1 mg/kg/12h starting as soon as treatment allocation arrives to obtain targeting troughs levels of 8-15 ng/ml the first 3 months, followed by trough levels of 5-10 ng/ml until the end of the study.
干预措施: PRE-TRANSPLANT (PRE=before) (Drug)
结局指标
主要结局
Percentage of biopsy-confirmed acute rejection episodes
时间窗: 6 months
To describe cumulative biopsy-confirmed acute rejection in both groups by intention to treat analysis.
次要结局
- Proteinuria measured in g/day(12 months)
- Histology at month 6 protocol kidney allograft biopsy(6 months)
- Percentage of patients with negative ELISPOT(12 months)
- Percentage of patients in group A requiring CNI introduction.(24 months)
- Percentage of patients presenting adverse events requiring study withdrawal(24 months)
- Percentage of biopsy-confirmed acute rejection episodes(12 months)
- Percentage of steroid-sensitive acute rejections rejection episodes(12 months)
- Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies(12 months)
- Percentage of steroid-sensitive acute rejection episodes(6 months)
- Percentage of acute rejection episodes requiring treatment with antilymphocyte antibodies.(6 months)
- Renal function estimated by Modification of Diet in Renal Disease (MDRD) formula.(12 months)
研究者
Josep M Grinyo
Chief of the Nephrology Department- Hospital Universitari de Bellvitge
Hospital Universitari de Bellvitge
研究点 (2)
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