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临床试验/ISRCTN60081949
ISRCTN60081949已完成未知

Calcineurin Inhibitor Minimisation in Renal Transplant recipients with Stable allograft function: A prospective randomised controlled trial

niversity Hospital Birmingham NHS Foundation Trust (UK)0 个研究点目标入组 90 人开始时间: 2007年8月22日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Adult recipients of a first kidney transplant
  • 2. A functioning kidney allograft (with estimated Glomerular Filtration Rate [eGFR] by Modification of Diet in Renal Disease [MDRD] >30 ml/min/1.73m^ 2) and be between 1 and 5 years post transplantation
  • 3. Stable allograft function, as defined by no greater than 10% rise in serum creatinine in the preceding 6 months, on ciclosporin and azathioprine based immunosuppression
  • 4. Minimal proteinuria, evidenced as urine albumin:creatinine ratio <50mg/mmol

排除标准

  • 1. <18 years of age
  • 2. Pregnancy or suspicion of pregnancy confirmed by positive b-HCG pregnancy test
  • 3. Female patients unwilling to take effective contraception for study duration
  • 4. Untreated ureteric obstruction on ultrasound of allograft
  • 5. Recurrent urosepsis
  • 6. Severe systemic infection
  • 7. Untreated significant (>50%) renal artery stenosis on magnetic resonance angiography performed prior to study
  • 8. History of acute allograft rejection
  • 9. History of myocardial infarction
  • 10. History of malignancy in previous 5 years (excluding non-melanomatous tumours limited to skin)
  • 11. Symptomatic ischaemic heart disease
  • 12. Hepatitis B surface antigen positive, hepatitis C positive or HIV positive
  • 13. Recipient of combined organ transplantation (e.g. pancreas / kidney; liver / kidney)
  • 14. Recipient of ABO-incompatible kidney
  • 15. Greater than 1 HLA mismatch at either the ?B? or ?DR? locus
  • 16. Peak HLA antibody Panel Reactivity (PRA) greater than 10%
  • 17. Recipient who underwent HLA desensitisation procedure prior to transplantation

研究者

发起方
niversity Hospital Birmingham NHS Foundation Trust (UK)

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