临床试验/2023-509156-34-02

2023-509156-34-02招募中4 期

VALIDGFR; method VALIDation and evaluation of non-radioactive methods to measure Glomerular Filtration Rate

Universitair Medisch Centrum Groningen1 个研究点分布在 1 个国家目标入组 200 人开始时间: 2024年6月5日最近更新: 2025年1月27日

试验速览

阶段: 4 期
状态: 招募中
发起方: Universitair Medisch Centrum Groningen
入组人数: 200
试验地点: 1
主要终点: mGFR determined using 125I-Iothalamate and 131I-hippuran

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine the equivalence of mGFR using 125I-iothalamate and 131I-hippuran versus iohexol

研究设计

研究类型: Interventional
分配方式: Not Applicable
主要目的: Second study visit (Part B)
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: 否

入选标准

•Scheduled to undergo a kidney function measurement test as part of standard care
•Age ≥ 18 years
•Written informed consent

排除标准

•History of hypersensitivity to iodinated contrast media or one of the excipients in the formulation of iohexol (trometamol, sodium calcium edetate, hydrochloric acid).
•Subjects with (suspected or known) thyrotoxicosis.
•Pregnant women and women of child-bearing potential who are not using reliable contraception
•Patients who are unlikely to comply to the trial’s procedure (non-compliance)

结局指标

主要结局

mGFR determined using 125I-Iothalamate and 131I-hippuran

mGFR determined using iohexol

次要结局

Repeated mGFR using iothalamate and hippuran on a separate study day(Through study completion, an average of 1 year)
Repeated mGFR using iohexol on a separate study day(Through study completion, an average of 1 year)

研究者

发起方

Universitair Medisch Centrum Groningen

申办方类型

Hospital/Clinic/Other health care facility

责任方

Principal Investigator

主要研究者

Ron T Gansevoort

Scientific

Universitair Medisch Centrum Groningen

研究点 (1)

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