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Sodium Iotalamate (125I)

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.

Table of Contents

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).[1] 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.[1]

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.[1]

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.[1]

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.[1]

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.[1]

The trial involves two parts:

  1. 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.
  2. 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.[1]

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.[1]

Aspect Details
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

FAQ

  • What is the purpose of using Sodium Iotalamate (125I) in these clinical trials? Sodium Iotalamate (125I) is being used to measure kidney function, specifically the glomerular filtration rate (GFR). The trials aim to compare this radioactive method with non-radioactive alternatives to determine which is most accurate and reliable for diagnosing kidney problems.
  • Who can participate in these clinical trials? Participants must be scheduled for a kidney function measurement test as part of their standard care and provide written informed consent. However, individuals with a history of hypersensitivity to iodinated contrast media, those with thyrotoxicosis, pregnant women, and those unlikely to comply with the trial procedures are excluded.
  • What does the clinical trial procedure involve? The trial involves two parts. In Part A, patients receive Sodium Iotalamate (125I) and another radioactive substance called 131I-hippuran during routine clinical care, along with a non-radioactive substance called iohexol. In Part B, some participants return after 10 days for a second round of measurements using the same substances.
  • Are there any risks associated with using Sodium Iotalamate (125I)? While the trial uses a low dose of radioactive material, there are some risks. People with hypersensitivity to iodinated contrast media or thyroid problems are excluded from the study. The researchers take precautions to minimize risks, and participants are closely monitored throughout the trial.
  • How might this research benefit patients with kidney problems? This research aims to improve the accuracy of kidney function measurements, which could lead to better diagnosis and management of chronic kidney disease. By comparing different methods, doctors may be able to choose the most appropriate and reliable test for each patient, potentially improving overall kidney care.

Ongoing Clinical Trials on Sodium Iotalamate (125I)

  • Study to Compare Non-Radioactive Methods for Measuring Kidney Function in Patients with Chronic Kidney Disease Using Sodium Iotalamate, Sodium Iodohippurate, and Iohexol

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • Glomerular Filtration Rate (GFR): A measure of how well the kidneys are filtering waste from the blood. It's an important indicator of kidney function.
  • Chronic Kidney Disease: A condition characterized by gradual loss of kidney function over time.
  • Sodium Iotalamate (125I): A radioactive substance used to measure kidney function in this clinical trial.
  • Iohexol: A non-radioactive contrast agent used in this study as an alternative method to measure kidney function.
  • mGFR: Measured Glomerular Filtration Rate, a direct method of assessing kidney function.
  • Thyrotoxicosis: A condition where there is too much thyroid hormone in the body, which can affect various bodily functions.
  • Intravenous bolus injection: A method of quickly administering a medication or substance directly into a vein.
  • Megabecquerel (MBq): A unit used to measure radioactivity, with one megabecquerel equal to one million decays per second.

References

  1. http://clinicaltrials.eu/trial/study-to-compare-non-radioactive-methods-for-measuring-kidney-function-in-patients-with-chronic-kidney-disease-using-sodium-iotalamate-sodium-iodohippurate-and-iohexol/