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Clinical Trial Details

Trial ID: L0066
Source ID: NCT06259422
Associated Drug: Iohexol
Title: Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate
Acronym: VALIDGFR
Status: NOT_YET_RECRUITING
Study Results: NO
Results:
Conditions: Kidney Function Issue|Diagnosis|Chronic Kidney Diseases
Interventions: DRUG: Iohexol|DIAGNOSTIC_TEST: 125I-iothalamate and 131I-hippuran
Outcome Measures: Primary: mGFR Iohexol, mGFR that is determined using the iohexol method, Through study completion, an average of 1 year|mGFR Iothalamate and hippuran, mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method, Through study completion, an average of 1 year | Secondary: Repeated mGFR using iohexol on a separate study day, mGFR that is determined using the iohexol method, Through study completion, an average of 1 year|Repeated mGFR using iothalamate and hippuran on a separate study day, mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method, Through study completion, an average of 1 year | Other: Subgroup analysis mGFR, A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on important patient characteristics. This will be assessed per subgroup depending on the glomerular filtration rate (GFR) of the patients (patients with a mGFR: \<30, 30-90, \>90), Through study completion, an average of 1 year|Subgroup analysis sex, A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the sex of the patient., Through study completion, an average of 1 year|Subgroup analysis age, A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the age of the patient., Through study completion, an average of 1 year|Subgroup analysis BMI, A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the BMI of the patient., Through study completion, an average of 1 year|Subgroup analysis creatinine, A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the creatinine levels of the patient., Through study completion, an average of 1 year|Subgroup analysis cystatin C, A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the cystatin C levels of the patient., Through study completion, an average of 1 year|Subgroup analysis BSA, A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the Body Surface Area (BSA) of the patient., Through study completion, an average of 1 year
Sponsor/Collaborators: Sponsor: University Medical Center Groningen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 208
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-06-01
Completion Date: 2025-09-01
Results First Posted:
Last Update Posted: 2024-03-13
Locations: University Medical Centre Groningen, Groningen, 9700 RB, Netherlands
URL: https://clinicaltrials.gov/show/NCT06259422