Chronic Kidney Diseases, Diagnosis, Kidney Function Issue
Conditions
Keywords
mGFR, Kidney function, Exogenous filtration marker, Measured glomerular filtration rate, Iohexol, Iothalamate
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.
Interventions
DRUGIohexol
Subjects will receive a single bolus of 5 mL of Omnipaque 300 (containing 3235 mg iohexol)
DIAGNOSTIC_TEST125I-iothalamate and 131I-hippuran
Subjects will receive 125I-iothalamate and 131I-hippuran as part of their routine clinical care.
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mGFR Iohexol | Through study completion, an average of 1 year | mGFR that is determined using the iohexol method |
| mGFR Iothalamate and hippuran | Through study completion, an average of 1 year | mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Subgroup analysis creatinine | Through study completion, an average of 1 year | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the creatinine levels of the patient. |
| Subgroup analysis mGFR | Through study completion, an average of 1 year | 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) |
| Subgroup analysis BSA | Through study completion, an average of 1 year | 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. |
| Subgroup analysis cystatin C | Through study completion, an average of 1 year | 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. |
| Subgroup analysis sex | Through study completion, an average of 1 year | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the sex of the patient. |
| Subgroup analysis age | Through study completion, an average of 1 year | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the age of the patient. |
| Subgroup analysis BMI | Through study completion, an average of 1 year | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the BMI of the patient. |
Countries
Netherlands
Contacts
Primary ContactAbdulfataah Mohamed, MSc
Backup ContactSecretariat Nephrology
Outcome results
None listed