2024-519757-11-00招募中3 期
PREDONATION KIDNEY RESERVE: IMPACT IN THE EVOLUTION OF DONOR AND RECIPIENT RENAL FUNCTION IN A RENAL TRANSPLANTATION PROGRAMME OF LIVING DONOR
University Hospital Of Canary Islands1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Renal function evolution measured in the donor and recipient after renal transplantation. Renal function will be measured with a reference standard, plasma clearance of iohexol. Renal reserve will be assessed by intravenous infusion of an amino acid solution.
研究概览
简要总结
To evaluate the evolution of post-transplant renal function in living donor transplant donors and recipients in relation to renal function and renal reserve of the donor before transplantation.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Predonation Kidney Reserve
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years.
- •Subjects (donor-recipient) referred to the Nephrology Service for inclusion in the living donor renal transplant programme and in whom no contraindication for donation/transplant has been detected.
- •Clinical stability, defined by the absence of intercurrent episodes during the last month, such as: acute infections, acute renal failure of any aetiology, cardiovascular disease, etc.
- •Signature of informed consent.
排除标准
- •Psychiatric illness that prevents compliance with this protocol (evaluation by psychiatrist and psychologist within the regular living donor programme).
- •Pregnancy and breastfeeding.
- •Inability to understand the protocol and its implications.
- •Cross-transplantation.
- •Transplants whose recipients require prior desensitization protocols.
- •Evidence of allergy to iodine or positive history of previous adverse reactions to contrast media.
- •Medical-surgical contraindications that advise against donation/transplantation and those for intravenous administration of amino acids, according to the technical data sheet.
- •Congenital errors of amino acid metabolism, especially those related to branched-chain amino acids, e.g. isovaleric acidemia.
- •Maple syrup urine disease.
- •Hypersensitivity to one or more of the amino acids present in the solution.
结局指标
主要结局
Renal function evolution measured in the donor and recipient after renal transplantation. Renal function will be measured with a reference standard, plasma clearance of iohexol. Renal reserve will be assessed by intravenous infusion of an amino acid solution.
Renal function evolution measured in the donor and recipient after renal transplantation. Renal function will be measured with a reference standard, plasma clearance of iohexol. Renal reserve will be assessed by intravenous infusion of an amino acid solution.
次要结局
未报告次要终点
研究者
Ana González Rinne
Scientific
University Hospital Of Canary Islands
研究点 (1)
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