MedPath

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

Phase 4
Recruiting
Conditions
Chronic Kidney Disease Kidney Failure
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

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
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Repeated mGFR using iothalamate and hippuran on a separate study dayThrough 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 dayThrough 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

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