EUCTR2005-001183-31-AT进行中（未招募）不适用
A prospective, open label, randomized, multicenter, multinational study evaluating the overall efficacy and safety including the effect on renal function of sirolimus (Rapamune?) replacing CNI in a standard care regimen of CNI, mycophenolate mofetil (MMF) and steroids in heart transplant patients - Heart ST
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients, age > 18
- •2.Patients receiving their first heart transplant (single organ transplant)
- •3.Patients on a standard care regimen of CNI, MMF and steroids since transplantation
- •4.Patients capable of understanding the purposes and risks of the study and who can give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria at Study Entry (4-6 weeks post-transplant):
- •1.Women of childbearing potential with a positive serum or urine pregnancy test or nursing mothers. Females of childbearing potential not using 2 reliable forms of contraception, including a barrier method, for the duration of the study and for 90 days after the last dose of study medication.
- •2.Patients with a positive donor-specific cross-match at the time of transplantation
- •3.Patients with any PRA > 25%
- •4.Patients with history of malignancy other than non-melanoma skin cancer that has been totally excised and who have shown no recurrence for 2 years
- •5.Patients with
- •a)Ejection fraction of = 40%
- •b)Ejection fraction of 20% decrease from baseline, and the need for inotropic agents
- •c)Fractional shortening =20% or a 25% decrease from baseline, and the need for inotropic agents
- •d)Need for inotropic agents due to a Cardiac Index (CI) <2.0 L/min/m2 or a 25% decrease from baseline
- •6.Patients with any antibody treated acute rejection
- •7.Patients with known contraindications to treatment with sirolimus
- •8.Patients with hemoglobin < 8.5g/dL, WBC value of <3000/mm3 or a platelet count of <50,000/mm3 unlikely to resolve prior to randomization
- •9.Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication unlikely to resolve prior to randomization
- •10.Patients participating in another interventional clinical trial or requiring treatment with un-marketed investigational drugs or who would be expected to require other medications prohibited by the protocol.
- •11.Patients who require revascularization prior to study entry (bypass, stenting, angioplasty)
- •Additional Exclusion Criteria at Randomization [12 (+/- 2) weeks post-transplant]:
- •1.All exclusion criteria as at Study Entry
- •2.Patients no longer on a standard care regimen of CNI, MMF and steroids
- •3.Patients not on HMG CoA reductase inhibitors (statins”)
- •4.Patients who require dialysis within 4 weeks prior to randomization
- •5.Patients with any biopsy proven acute rejection = ISHLT grade 3A within 4 weeks prior to randomization
- •6.Patients with any biopsy proven acute rejection = ISHLT grade 3A more than 4 weeks prior to randomization without a subsequent biopsy of ISHLT grade 0 or IA
- •7.Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication
- •8.Sepsis or any severe active infection requiring IV antibiotics and/or hospitalization within the 2 weeks prior to randomization
- •Patients who received sirolimus before randomization
研究者
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