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临床试验/CTRI/2026/01/100127
CTRI/2026/01/100127尚未招募不适用

Prospective randomized comparative study of graft rejection between Prolonged Release Tacrolimus and Azathioprine vs. Immediate Release Tacrolimus and Mycophenolate Mofetil in Living Donor Liver Transplant recipients

Dr Subhash Gupta1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2026年1月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
168
试验地点
1

研究概览

简要总结

This is a single centre, prospective, randomized, open label, phase 4 clinical trial in adult living donor liver transplant recipients. The study will compare two tacrolimus based immunosuppressive regimens. One group will receive prolonged release tacrolimus with azathioprine. The other group will receive immediate release tacrolimus with mycophenolate mofetil. The primary objective is to compare the incidence of biopsy proven acute graft rejection in the first year after transplant. Secondary objectives include comparison of patient and graft survival, renal function, and serious infections during follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All patients aged 18 years and above undergoing LDLT.
  • All patients should be receiving Liver from first degree relatives only (grandparents, parents, siblings or children, grandchildren).
  • All patients in which immunosuppression could be commenced within 24 hours of transplant according to study protocol.

排除标准

  • All patients with a past history of malignancy other than Liver tumours
  • Simultaneously receiving other organ transplants
  • Serological evidence of HIV positivity
  • ABO incompatible transplants
  • ACLF grade 3
  • Patients with Chronic Kidney Disease planned for sequential or combined kidney transplant
  • Not willing to give consent.

研究者

发起方
Dr Subhash Gupta
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Prof Dr Subhash Gupta

Max Super Specialty Hospital

研究点 (1)

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