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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iohexol in addition to 125I-iothalamate and 131I-hippuran | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iohexol | Drug | Subjects will receive a single bolus of 5 mL of Omnipaque 300 (containing 3235 mg iohexol) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdulfataah Mohamed, MSc | Contact | +31503612955 | a.a.a.mohamed@umcg.nl | |
| Secretariat Nephrology | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Groningen | Groningen | 9700 RB | Netherlands |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| 125I-iothalamate and 131I-hippuran | Diagnostic Test | Subjects will receive 125I-iothalamate and 131I-hippuran as part of their routine clinical care. |
|
mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method
| 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 |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |