EUCTR2007-003649-34-GB进行中（未招募）1 期
RENAL RESCUE IMMUNOSUPPRESSION FOLLOWING HEART TRANSPLANTATION - RRescue Trial
niversity Hospital of South Manchester NHS Foundation Trust0 个研究点目标入组 56 人开始时间: 2008年6月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 56
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
入选标准
- •1.Stable patients more than 6 months after heart transplantation, receiving immunosuppression based on cyclosporine or tacrolimus.
- •2.Moderate renal impairment - serum creatinine 150-220 micro mol/l or GFR (glomerular filtration rate) 30-59, in the 3 months period prior to enrolment in the study.
- •3.Patients who have given written informed consent to take part in the study.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Acute rejection (grade 3a or above from the ISHLT criteria) requiring treatment in the last 3 months.
- •2.Alternative causes for renal dysfunction (e.g. renal obstruction, small kidneys or other gross abnormalities).
- •3.Females of childbearing potential who are planning to become pregnant, who are pregnant who are unwilling to use effective means of contraception. Patients should use a reliable medically approved method of contraception during the trial period. If unwilling or unable to use a medically approved reliable form of contraception then patients should abstain from penetrative sex.
- •It is recommended that MMF or Myfortic therapy should not be initiated until a negative pregnancy test has been obtained. Effective contraception must be used before beginning MMF / Myfortic therapy, during therapy, and for six weeks following discontinuation of therapy. Patients should be instructed to consult their physician immediately should pregnancy occur.
- •The use of MMF / Myfortic is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available. MMF / Myfortic should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus. There are no adequate data from the use of MMF / Myfortic in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.
- •Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats. It is not known whether this substance is excreted in human milk. Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, MMF / Myfortic are contraindicated in nursing mothers.
- •4.Pre-existing severe cardiac allograft dysfunction (LVEF < 40%).
- •5.Hb persistently (on 3 consecutive occasions) < 10 g/dl, white cell count persistently (on 3 consecutive occasions) < 4.0 x 109/l.
- •6.Platelets persistently (on 3 consecutive occasions) < 100 x 109/l
- •7.Heavy proteinuria without any evidence of urinary infection (>1g/24hrs)
研究者
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