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临床试验/NCT05717842
NCT05717842招募中不适用

Simultaneous Prospective Kidney Transplant Assessment in Combined Liver Kidney

Indiana University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
perform a nuclear medicine scan prior to SLK transplant

研究概览

简要总结

The purpose of the study is to determine how much a persons kidney function recovers after receiving a simultaneous liver kidney transplant. The investigators will be contacting patients with kidney dysfunction with estimated GFR between 25 and 40 (not on dialysis treatment) who are listed to receive a simultaneous liver kidney (SLK) transplant to look at this function recovery. The investigators hope to develop a criteria based on GFR measurement, kidney function calculations from native kidneys vs transplanted kidney and compare the contributions, and correlate with estimated GFR on basic metabolic panel (BMP: a blood test) to predict higher chances of recovery of native kidney function.

详细描述

Study design

Study will be a pilot longitudinal prospective study. SLK transplant listed patients will be recruited from the outpatient Liver Kidney Transplant Clinic at Medical Diagnostic Clinic (MDC) as well as inpatients admitted to IU University Hospital. Listing status for SLK transplant will be confirmed and patients will be scheduled for a Mag3 nuclear medicine scan at IU University Department of Nuclear medicine. For study purposes, this scan will be done pre and post-transplant to compare the results.

Methods:

Inclusion/Exclusion criteria:

Inclusion:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • > 18 years old
  • Listed for Liver Transplant for ESLD and Kidney Transplant (not on dialysis at time of transplant surgery)
  • Candidates with two native kidneys.
  • Willing to participate and sign informed consent form.

排除标准

  • Unstable patients (e.g. in the ICU or those who are on Continuous Renal Replacement Therapy (CRRT) who cannot complete the nuclear medicine scan or those with AKI on Hemodialysis
  • Prior history of any solid organ transplant.
  • Those who are currently pregnant or breast feeding.
  • Patients who have Autosomal Dominant polycystic kidney disease

研究组 & 干预措施

People with ESLD and eGFR between >=25 and <=40ml/min

  1. > 18 years old
  2. Listed for Liver Transplant for ESLD and Kidney Transplant (not on dialysis)
  3. Candidates with two native kidneys.
  4. Willing to participate and sign informed consent

干预措施: Nuclear Medicine Scan (Radiation)

结局指标

主要结局

perform a nuclear medicine scan prior to SLK transplant

时间窗: up to 100 weeks

To determine split kidney function with a Mag3 (Mercaptoacetyltriglycine 3) nuclear medicine renal scan as part of the study procedures.

次要结局

  • To measure and correlate Clinical, laboratory and Radiographic data at the time of SLK transplant will be reviewed(up to 100 weeks)

研究者

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

Muhammad Yahya Jan

Assistant Professor of Clinical Medicine

Indiana University

研究点 (1)

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