NCT06259422

Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.

Conditions

• Kidney Function Issue
• Diagnosis
• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	Iohexol	Subjects will receive a single bolus of 5 mL of Omnipaque 300 (containing 3235 mg iohexol)
DIAGNOSTIC_TEST	125I-iothalamate and 131I-hippuran	Subjects will receive 125I-iothalamate and 131I-hippuran as part of their routine clinical care.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-02-14
• Last updated: 2024-03-13

Locations

1 site across 1 country: Netherlands