ISRCTN74429508未知未知
A randomized multicenter trial to assess the efficacy of a combined therapy with Sirolimus (Rapamune®), MMF (Cellsept®) and corticosteroids after early elimination of cyclosporin compared to a standard immunosuppression with cyclosporin, MMF and corticosteroids in patients after kidney transplantatio
niversity of Munich - Department of Surgery (Germany)0 个研究点目标入组 140 人开始时间: 2005年10月4日最近更新:
试验速览
- 阶段
- 未知
- 发起方
- 入组人数
- 140
研究概览
简要总结
2010 results in https://pubmed.ncbi.nlm.nih.gov/20463641/ (added 07/07/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female patients between 18 and 60 years of age
- •2. Primary or secondary kidney allograft recipients (PRA <30%)
- •3. No requirement for dialysis since three days before randomization
- •4. Women of childbearing potential must have a negative qualitative pregnancy test before Sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for three months following discontinuation of Sirolimus. Any woman becoming pregnant during the treatment period must discontinue Sirolimus treatment
- •5. Signed and dated informed consent
排除标准
- •1. Multiorgan transplant recipients
- •2. Cold ischemia time >36 hours
- •3. PRA > 30%
- •4. Postoperative technical complications necessitating re operation (e.g. kidney artery stenosis) or wound healing disturbances (e.g. voluminous lymphoceles)
- •5. Recipients of A-B-0 incompatible grafts
- •6. Body mass index >32
- •7. Patients with cardiac infarction within six months before study entry or actual unstable coronary heart disease
- •8. Total number of neutrophile granulocytes <1,500/mm^3 or leucocytes <2,500/mm^3 at screening
- •9. Patients with severe hepatic impairment (glutamic-oxaloacetic transaminase
- •[GOT], glutamic-pyruvic transaminase [GPT], total bilirubin above three times the norm)
- •10. Total cholesterol >300 mg/dl and triglycerides >400 mg/dl (even under lipid lowering treatment)
- •11. Patients with severe intestinal disorders or other diseases significantly influencing resorption, distribution, metabolism and elimination of study medication (except diabetes) at the discretion of the investigator
- •12. Recipients positive for hepatitis B surface antigens or human immunodeficiency virus (HIV), organs from donors positive for hepatitis B surface antigens or HIV
- •13. Active malignancies within two years before study entry with the exception of squamous cell carcinoma and basal cell carcinoma of the skin
- •14. Patients with active systemic infections or significant coagulopathy or requirement of long term anticoagulation therapy after transplantation
- •15. Use of any investigational drug within four weeks before study entry
- •16. Known intolerability of Cyclosporine, Sirolimus, MMF or other medication required after transplantation
- •17. Patients with diseases which potentially could impair study performance at the discretion of the investigator
- •18. Pregnancy and lactation
- •19. Refusal to sign informed consent form
- •20. Patients with ongoing requirement of dialysis at time of randomization
研究者
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