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

Phase 4

Recruiting

• Conditions: Chronic Kidney Disease Kidney Failure
• Interventions: Drug: Iohexol; Diagnostic Test: 125I-iothalamate and 131I-hippuran

• Registration Number: 2023-509156-34-02
• Lead Sponsor: Universitair Medisch Centrum Groningen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-06-05
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

Scheduled to undergo a kidney function measurement test as part of standard care

Age ≥ 18 years

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: Not specified

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

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)

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Universitair Medisch Centrum Groningen

🇳🇱Groningen, Netherlands

Ron Gansevoort

Site contact

+310503612955

r.t.gansevoort@umcg.nl