EUCTR2009-013074-41-SE进行中（未招募）不适用
A controlled randomized open-label multicentre study evaluating if early initiation of everolimus (Certican®)and early elimination of cyclosporine (Sandimmun Neoral®) in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy. - Schedule
ovartis Norge AS0 个研究点目标入组 100 人开始时间: 2009年8月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •To be fulfilled at the time of transplantation and before entering period 1 of the study
- •- Male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
- •- Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 12 months
- •- Patients received induction therapy with ATG (Thymoglobulin)
- •At time of entering period 2:
- •- Patients completed period 1 on the maintained immunosuppressive regimen they were randomized to within the target doses and levels specified for each group.
- •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
- •To be fulfilled at the time of transplantation and before entering period 1 of the study
- •1. Recipient of multi-organ transplants or previously transplanted organs
- •2. Patients with donor greater than 70 years
- •3. Donor heart cold ischemic time > 6 hours.
- •4. Patients who are recipients of ABO incompatible transplants
- •5. Patients with platelet count < 50,000/mm3 at the evaluation before
- •6. Patient who have received an unlicensed drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation
- •7. Patient with a known hypersensitivity to cyclosporine
- •8. Patient with a current severe systemic infection
- •9. Patient unable to participate in the study for the full 12-month period
- •10. Presence of severe hypercholesterolemia (= 350 mg/dL; = 9 mmol/L) or hypertriglyceridemia (= 750 mg/dL; = 8.5 mmol/L)
- •11. Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma)
- •12. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility.
- •13. Patients with HIV, hepatitis B or C
- •At time of entering period 2:
- •1. Graft loss
- •2.Patients with ongoing treatment for rejection
- •3. Patients that have experienced a biopsy proven ISHLT grade 3R rejection or two or more grade 2R rejections during period 1
- •4. Patients who have experienced a humoral (antibody mediated) rejection with a hemodynamic compromise during period 1
- •5. Patients with a hemoglobin count < 8,0 g/dl (5.0 mmol/l); and/or a platelet count < 50 x 109/l and/or white blood cell count < 2.5 x 109/l)
- •6.Patients with total cholesterol (TC) >9 mmol/l and or triglycerides (TG) >6 mmol/l despite lipid lowering treatment
- •7.Patients with ongoing wound healing problems or other severe surgical complication in the opinion of the investigator
- •8.Patient with a current clinically severe systemic infection
研究者
相似试验
进行中（未招募）
不适用
A controlled randomized open-label multicentre study evaluating if early initiation of everolimus (Certican®) and early elimination of cyclosporine (Sandimmun Neoral®) in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy. - SCHEDULEHeart transplantationMedDRA version: 14.1Level: PTClassification code 10019314Term: Heart transplantSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2009-013074-41-DKovartis Healthcare A/S100
进行中（未招募）
1 期
A controlled randomized open-label multicentre study evaluating if early initiation of everolimus (Certican®)and early elimination of cyclosporine (Sandimmun Neoral®) in de novo heart transplant recipients can improve long-term renal function and slow down the progression of chronic allograft vasculopathy. - ScheduleHeart transplantationMedDRA version: 12.1Level: LLTClassification code 10019314Term: Heart transplantEUCTR2009-013074-41-NOovartis Norge AS
进行中（未招募）
不适用
A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy - CENTRAEUCTR2007-000771-42-SEovartis Pharma Services250
进行中（未招募）
不适用
A controlled randomized open-label multicentre study evaluatiing if early conversion to everolimus (Certican) from cyclosporine (Neoral) in de novo renal transplant receipients can improve long-term renal function and slow down the progression of chronic allograft nephropathy - CENTRAEUCTR2007-000771-42-DKovartis Pharma Services200
招募中
1 期
INTERCEPT StudyCTIS2024-510615-29-00Vaestra Goetalandsregionen50