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临床试验/NCT04154267
NCT04154267进行中(未招募)不适用

Utility Evaluation of Protocolar Renal Transplant Biopsies in High Risk Patients for Immunological Loss of Graft

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 119 人开始时间: 2020年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
119
试验地点
2
主要终点
Incidence of rejection.

研究概览

简要总结

The present study aims to evaluate the usefulness of protocol biopsies in a cohort of renal transplant patients of high immunological risk for graft injury and loss.

详细描述

This will be a prospective study undertaken at the Renal Transplant Unit of Hospital of Clinics of Porto Alegre. In addition to the routine evaluation commonly carried-out at this post-transplant period, protocol biopsies will be performed at the 10th-week post-transplantation in high-risk transplant recipients. Biopsy fragments will be evaluated for tissue immune aggression (mainly cellular and antibody-mediated rejections) and other conditions such as infections, particularly polyomavirus and cytomegalovirus and medication toxicities. The presence of donor-specific antibodies and graft-damaging infectious agents will also be searched in the peripheral blood at the time of biopsy.One hundred patients will be randomized to a protocol biopsy and noninvasive assessment or only for noninvasive assessment. The hypothesis of the study is that biopsies will lead to treatments that may allow better outcomes of renal transplants, related to lowering the progression of subclinical aggressions, avoiding or delaying graft loss and preserving or decreasing the rate of loss of the glomerular filtration rate. Therefore, this strategy has the possibility of reaching clinical practice routine and thus contribute positively to the management of renal transplant patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult kidney transplants, with high immunological risk, who consented to participate in the study by signing the informed consent form. The high immune risk is defined by:
  • Positive pre-transplant T-lymphocyte cross-test by flow cytometry (channel deviation greater than 62);
  • Flow cytometry pre-transplantation positive B lymphocyte cross-test (channel deviation greater than 112);
  • Calculated panel reactivity greater than 50% in class I and / or class II;
  • Presence in the pre-transplantation serum of donor class I and / or II anti-Human Leukocyte Antigen antibodies with intensity and fluorescence greater than 1000;
  • Occurrence of cellular or antibody-mediated rejection within 30 days prior to the date of the protocol biopsy.

排除标准

  • Patients with contraindication to renal graft biopsy;
  • Patients whose biopsy fragments are not representative;
  • Patients with graft dysfunction in whom renal graft biopsy is indicated within 4 weeks prior to protocol biopsy.

结局指标

主要结局

Incidence of rejection.

时间窗: Three months post transplant.

To evaluate the incidence of subclinical, cellular and antibody-mediated rejections in protocol biopsies performed on patients at high immune risk who underwent kidney transplantation.

次要结局

  • Graft survival(Two years post transplant.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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