EUCTR2007-000789-19-BE进行中（未招募）不适用
Withdrawal of Calcineurin Inhibitors (CNIs) during administration of Mycophenolate Mofetil (MMF) in liver transplant patients suffering adverse effects from CNIs: Study of the reduction in rejection risk by therapeutic drug monitoring of Mycophenolate Mofetil - MiniCept
CHU de Liège, Domaine Universitaire du Sart Tilman0 个研究点开始时间: 2007年4月23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
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) Male or female patient aged 18 years or older
- •2) Patient has signed informed consent
- •3) Patient is able to understand the purpose of the trial
- •4) First liver transplant or retransplant with delay post-LT of 2 to 10 years
- •5) Transplantee presenting with adverse effects from anticalcineurins:
- •- Kidney insufficiency defined by creatinine clearance < 50 ml/mn (calculated or
- •estimated according to the Cockcroft formula) or a decrease of creatinine
- •clearance of = 30 ml/mn since transplantation (first month)
- •- Arterial hypertension not controlled by bitherapy and defined by arterial
- •pressure of >140/90 measured after 10 min rest in laying position
- •- Diabetes (Fasting glycaemia > 7.0 mmol/l), whether treated or not
- •- Neuromuscular toxicity
- •6) Bitherapy with Cyclosporin and MMF or Tacrolimus and MMF
- •- Cyclosporin concentration C0 = 100 ng/ml or C2 = 500 ng/ml, OR
- •- Tacrolimus concentration = 6 ng/ml
- •7) Liver biopsy performed in the 6 months preceding inclusion for patients with a
- •post-transplant period of < 5 years and in the 12 months preceding inclusion for
- •patients with a post-transplant period of > 5 years
- •8) Negative pregnancy test for women of childbearing potential and reliable
- •contraception for women of childbearing potential. Contraception must be used
- •before start of treatment with CellCept, duringf treatment, and 6 weeks after the
- •last dose of CellCept
- •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
- •1) Patient participating in another trial
- •2) Acute rejection in the 6 months preceding screening
- •3) History of corticoresistant rejection
- •4) Chronic rejection
- •5) Significant ductopenia (absence of interlobular biliary ducts in more than 30 % of
- •the portal spaces) in the pre-screening graft biopsy.
- •6) Pre-transplant diabetes (fasting glycaemia > 7.0 mmol/l), whether treated or not,
- •except for cases of diabetes which resolved after transplantation
- •7) LT for auto-immune hepatitis or primary sclerosing cholangitis
- •8) Transplantation due to C virus cirrhosis with reinfection lesions of the
- •transplanted organ which may require treatment with interferon-ribavirine in the
- •year following inclusion
- •9) Contraindications to MMF (Hb < 10g/dl, Neutrophils < 1000/mm3)
- •10) Immunosuppression with Rapamycin or Azathioprin
- •11) A woman who is, or might become, pregnant or is lactating
- •12) Creatinine clearance < 25ml/mn
- •13) Double liver / kidney trasplant
研究者
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