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临床试验/NCT05431712
NCT05431712已完成不适用

Impact of Donor-Specific Antibodies in (Highly-) Immunized Living Donor Kidney Transplant Recipients

Erasmus Medical Center0 个研究点目标入组 252 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
252
主要终点
Death-censored graft survival

研究概览

简要总结

Kidney transplantation is the preferred treatment for end-stage renal disease. Alongside limited availability of donors, rejection and premature graft loss are main barriers to kidney transplantation. Donor-specific antibodies pre-transplantation may arise due to to prior solid organ transplantation, pregnancy or blood transfusions. Their presence is considered a risk of graft failure. The impact of DSA is differently reported in literature, also according to the technique by which DSA have been measured. Techniques such as the complement-dependent cytotoxicity crossmatch, the immunofluorescence crossmatch and the Luminex Single Antigen Bead have different sensitivities for detecting DSA.

Historically, our kidney transplant program has been advocating living donor transplantation and as a result the majority of transplantations are with a living donor. In this context and in the absence of a compatible living donor, pretransplant DSA have not been considered an absolute contra-indication for transplantation. The aim of the current study is to determine the effect of DSAs on rejection and death-censored graft survival in living donor kidney transplantation.

Participants are adults who underwent a living donor kidney transplantation between 2010 and 2019 in the presence of DSA. Control subjects are both immunized and non-immunized kidney transplant recipients in the same period.

This is a retrospective, case control study. Death-censored graft survival is analyzed for all patients and compared by presence of DSA and other predicting variables, such as immunization level, age, sex and HLA mismatches. Furthermore, biopsy proven rejection, patient survival, kidney function, length of hospital stay and proteinuria are analyzed.

Also, a predefined subgroup analysis is performed in the DSA positive patients. These are compared according to amount, strength and HLA-class of DSAs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pre-transplantation donor-specific antibodies in Luminex Single Antigen Bead analysis.
  • Age 18 years or older

排除标准

  • Desensitization treatment for a current or historic positive CDC-crossamtch

结局指标

主要结局

Death-censored graft survival

时间窗: 4-12 years

Amount of patients who were alive with a functioning graft, divided by all alive included patients at different moments in time.

次要结局

  • Patient survival(4-12 years)
  • Biopsy proven rejection(4-12 years)
  • Hospital admission days(first year post-transplantation)
  • Renal function(first year post-transplantation)
  • Proteinuria(first year post-transplantation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Annelies de Weerd, MD, PhD

MD, PhD, Principal investigator

Erasmus Medical Center

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