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

Not Applicable

Not yet recruiting

• Conditions: Chronic Kidney Diseases; Kidney Function Issue; Diagnosis
• Interventions: Drug: Iohexol; Diagnostic Test: 125I-iothalamate and 131I-hippuran

• Registration Number: NCT06259422
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-14
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Study Start: 2024-06-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

• Scheduled to undergo a kidney function measurement test as part of standard care.
• Written informed consent.

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iohexol in addition to 125I-iothalamate and 131I-hippuran	125I-iothalamate and 131I-hippuran	In this clinical trial, patients receiving 125I-iothalamate and 131I-hippuran during routine clinical care, will also receive iohexol. This allows us to determine the mGFR using both methods in the same patient, and compare both methods in terms of accuracy and precision.
Iohexol in addition to 125I-iothalamate and 131I-hippuran	Iohexol	In this clinical trial, patients receiving 125I-iothalamate and 131I-hippuran during routine clinical care, will also receive iohexol. This allows us to determine the mGFR using both methods in the same patient, and compare both methods in terms of accuracy and precision.

Primary Outcome Measures

Name	Time	Method
mGFR Iothalamate and hippuran	Through study completion, an average of 1 year	mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method
mGFR Iohexol	Through study completion, an average of 1 year	mGFR that is determined using the iohexol method

Secondary Outcome Measures

Name	Time	Method
Repeated mGFR using iothalamate and hippuran on a separate study day	Through study completion, an average of 1 year	mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method
Repeated mGFR using iohexol on a separate study day	Through study completion, an average of 1 year	mGFR that is determined using the iohexol method

Trial Locations

Locations (1)

University Medical Centre Groningen; 🇳🇱 Groningen, Netherlands