In short
Clinical trials are exploring the use of Sodium Iotalamate (125I) as a diagnostic tool for measuring kidney function in patients with chronic kidney disease. This radioactive substance is being compared to non-radioactive methods to determine the most accurate way to assess glomerular filtration rate (GFR), a key indicator of kidney health. The study aims to improve diagnostic techniques and provide better care for individuals with kidney-related conditions.
At a glance
- Study Title
- VALIDGFR: Method validation and evaluation of non-radioactive methods to measure Glomerular Filtration Rate
- Main Objective
- To determine the equivalence of mGFR using 125I-iothalamate and 131I-hippuran versus iohexol
- Medical Condition
- Chronic Kidney Disease, Kidney Failure
- Key Inclusion Criteria
- Scheduled for kidney function measurement as part of standard care; Written informed consent
- Key Exclusion Criteria
- Hypersensitivity to iodinated contrast media; Thyrotoxicosis; Pregnancy; Non-compliance
- Study Design
- Two parts: Routine clinical care visit (Part A) and Second study visit after 10 days (Part B)
- Primary Endpoints
- mGFR determined using 125I-Iothalamate and 131I-hippuran; mGFR determined using iohexol
- Drug Information
- Sodium Iotalamate (125I), Solution for injection, Max daily dose: 3.7 MBq
- Administration Route
- Intravenous bolus injection/IV infusion
What is Sodium Iotalamate (125I)?
Sodium Iotalamate (125I) is a diagnostic medication used to measure kidney function. It is a solution for injection that contains a radioactive form of iodine (125I). This medication is primarily used in medical settings to accurately assess how well your kidneys are working.
Medical Uses
The main use of Sodium Iotalamate (125I) is to measure kidney function in patients with chronic kidney disease or kidney failure. It helps doctors determine the glomerular filtration rate (GFR), which is a key indicator of how well your kidneys are filtering waste from your blood.
How It Works
Sodium Iotalamate (125I) works by allowing doctors to measure what's called the measured GFR (mGFR). When injected into your bloodstream, this substance is filtered by your kidneys in a predictable way. By measuring how quickly it's removed from your blood, doctors can calculate how well your kidneys are functioning.
Administration
Sodium Iotalamate (125I) is given as an intravenous bolus injection or IV infusion. This means it's injected directly into your vein, either as a quick injection (bolus) or as a slower infusion over time.
Dosage
The maximum daily dose and total dose of Sodium Iotalamate (125I) is 3.7 MBq (megabecquerels). MBq is a unit used to measure radioactivity. This dose is typically administered over the course of one day.
Clinical Trial Information
A clinical trial called VALIDGFR is currently studying Sodium Iotalamate (125I) along with other methods to measure kidney function. The main goal of this trial is to compare the effectiveness of Sodium Iotalamate (125I) with other non-radioactive methods for measuring GFR.
The trial involves two parts:
- Part A: Patients receive Sodium Iotalamate (125I) along with another radioactive substance (131I-hippuran) and a non-radioactive substance (iohexol) during a routine clinical care visit.
- Part B: Some patients return after 10 days for a second measurement using the same substances.
This study aims to determine if the non-radioactive method (using iohexol) is as accurate as the radioactive methods for measuring kidney function.
Precautions and Contraindications
While Sodium Iotalamate (125I) is generally considered safe for diagnostic use, there are some situations where it should not be used. These include:
- History of hypersensitivity (allergic reaction) to iodinated contrast media
- Known or suspected thyrotoxicosis (overactive thyroid gland)
- Pregnancy or women of childbearing age not using reliable contraception
It's important to inform your healthcare provider about any medical conditions or medications you're taking before undergoing this test.