A randomised controlled trial comparing the use of sirolimus based biphasic immunosuppression with myfortic to allow early CalciNeurin Inhibitor (CNI) withdrawal in renal transplantatio

niversity Hospitals of Leicester NHS Trust (UK)0 个研究点目标入组 42 人开始时间: 2007年10月16日最近更新: 2015年1月13日

适应症

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•Patients will be eligible for the trial if all of the following criteria are met:
•1. Age greater than or equal to 18 years
•2. Patients receiving a primary or secondary renal allograft from a living related, living unrelated or heart-beating cadaveric donor
•3. Patients with second transplants must have maintained their primary graft for at least six months after transplantation (with the exception of graft failure due to technical reasons)
•4. Stable renal allograft function over the first 3 months post transplant
•5. An absence of subclinical rejection on the 3 month protocol biopsy
•6. A negative pregnancy test pre-protocol biopsy
•7. Signed written informed consent

•Patients will not be eligible for the trial if any of the following criteria apply:
•1. Kidney transplantation from a non heart-beating donor
•2. Patients suffering an acute rejection episode in the first 3 months post transplant with a Banff classification of 1b or above
•3. Sub-clinical rejection seen in the 3-month protocol biopsy
•4. Proteinuria >500 mg/24 hours
•5. Estimated Glomerular Filtration Rate (eGFR) <40 mls/min (Cockcroft-Gault formula)
•6. Evidence of active systemic or localised major infection at study entry
•7. Known hypersensitivity to Tacrolimus, macrolide antibiotics or Myfortic
•8. Use of any investigational drug or treatments within 28 days before study entry
•9. Known or suspected malignancy within five years before study entry
•10. Any condition which in the opinion of the investigator makes the patient unsuitable for entry into the study

发起方

niversity Hospitals of Leicester NHS Trust (UK)