Clinical trial NCT06259422: Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate
Official title: Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Kidney Function Issue
Diagnosis
Chronic Kidney Diseases
Keywords: mGFR
Kidney function
Exogenous filtration marker
Measured glomerular filtration rate
Iohexol
Iothalamate
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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).

Primary outcomes:
measure: mGFR Iohexol
timeFrame: Through study completion, an average of 1 year
measure: mGFR Iothalamate and hippuran
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Repeated mGFR using iohexol on a separate study day
timeFrame: Through study completion, an average of 1 year
measure: Repeated mGFR using iothalamate and hippuran on a separate study day
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Subgroup analysis mGFR
timeFrame: Through study completion, an average of 1 year
measure: Subgroup analysis sex
timeFrame: Through study completion, an average of 1 year
measure: Subgroup analysis age
timeFrame: Through study completion, an average of 1 year
measure: Subgroup analysis BMI
timeFrame: Through study completion, an average of 1 year
measure: Subgroup analysis creatinine
timeFrame: Through study completion, an average of 1 year
measure: Subgroup analysis cystatin C
timeFrame: Through study completion, an average of 1 year
measure: Subgroup analysis BSA
timeFrame: Through study completion, an average of 1 year
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
Study officials:
References: