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

University Medical Center Groningen (UMCG)

Status: Not yet enrolling

Conditions: Chronic Kidney Diseases; Diagnosis; Kidney Function Issue

Treatments: Drug: Iohexol; Diagnostic Test: 125I-iothalamate and 131I-hippuran

Study type: Interventional

Funder types: Other

Identifiers

NCT06259422

18054

Details and patient eligibility

About

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.

Enrollment: 208 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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208 participants in 1 patient group

Iohexol in addition to 125I-iothalamate and 131I-hippuran

Other group

Description:

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.

Treatment:

Drug: Iohexol

Diagnostic Test: 125I-iothalamate and 131I-hippuran