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Study on the Effect of Dapagliflozin on Blood Magnesium Levels in Patients with Low Magnesium Due to HNF1beta-Associated Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of the medication dapagliflozin on blood magnesium levels in patients with low magnesium due to a specific kidney disease associated with the HNF1beta gene mutation. This condition, known as hypomagnesemia, results in lower than normal levels of magnesium in the blood, which can affect various bodily functions. The study aims to understand how dapagliflozin, a medication typically used to lower blood sugar, can influence magnesium levels in both diabetic and non-diabetic patients with this genetic kidney condition.

Participants in the study will receive either dapagliflozin or a placebo in the form of a tablet taken orally. The treatment period will last for a total of four weeks. During this time, the main focus will be on observing any changes in the levels of magnesium in the blood. The study is designed to provide insights into whether dapagliflozin can help improve magnesium levels in patients affected by this specific genetic mutation.

The purpose of this study is to evaluate the potential benefits of using dapagliflozin for managing low magnesium levels in patients with HNF1beta-associated kidney disease. By participating in this trial, researchers hope to gather valuable information that could lead to better treatment options for individuals with this condition. The study will be conducted over a set period, and participants will be monitored closely to ensure their safety and to accurately assess the effects of the treatment.

1 joining the study

Participation begins after meeting specific criteria: a confirmed diagnosis of HNF1beta disease, low magnesium levels in the blood, age between 18 and 75 years, and providing informed consent.

2 initial assessment

An initial assessment is conducted to establish baseline health data. This includes measuring blood magnesium levels and other relevant health indicators.

3 medication administration

The study involves taking a medication called dapagliflozin or a placebo. The medication is taken orally, once daily, at a dose of 10 mg.

The purpose of the medication is to evaluate its effect on blood magnesium levels in patients with low magnesium due to HNF1beta-associated kidney disease.

4 ongoing monitoring

Regular monitoring of blood magnesium levels and other health parameters is conducted throughout the study period to assess any changes or effects of the medication.

5 completion of the study

The study is expected to conclude by July 1, 2025. At the end of the study, a final assessment is conducted to evaluate the overall effect of the medication on blood magnesium levels.

Who Can Join the Study?

  • Must have a genetically proven condition called HNF1beta disease. This means that a specific genetic test has confirmed the presence of this condition.
  • Must have renal hypomagnesemia, which means having low levels of magnesium in the blood, specifically less than 0.70 mmol/l.
  • Must be between the ages of 18 and 75 years.
  • Must provide informed consent, which means agreeing to participate in the study after understanding all the details and implications.

Who Cannot Join the Study?

  • Patients with a known allergy or sensitivity to the study medication or its ingredients cannot participate.
  • Individuals who are currently participating in another clinical trial are not eligible.
  • Patients with severe kidney disease, which means their kidneys are not working well, are excluded.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Individuals with a history of certain heart conditions, such as heart failure, are not allowed to join.
  • Patients with uncontrolled diabetes, meaning their blood sugar levels are not stable, are excluded.
  • Anyone with a history of alcohol or drug abuse, which means using these substances in a harmful way, cannot participate.
  • Individuals with certain liver diseases, where the liver is not functioning properly, are not eligible.
  • Patients who have had a recent major surgery, which is a significant medical operation, are excluded.
  • Individuals with any other medical condition that the study doctors believe would make it unsafe for them to participate are not allowed to join.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands
Ajkxclhua Upn Amsterdam The Netherlands
Ezpumtb Uftjbpewidby Mvvaszl Cymrgtb Rziqtabdk (tkrtzuz Mmz Rotterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
21.10.2024

Trial locations

Investigated drugs:

Dapagliflozin is a medication used in this clinical trial to study its effect on serum magnesium levels. It works by inhibiting a protein called SGLT2, which helps the kidneys remove glucose from the bloodstream. In this trial, researchers are interested in seeing how this medication affects patients with a specific condition called HNF1beta-associated renal hypomagnesemia, which is a problem with low magnesium levels in the blood.

Investigated diseases:

Hypomagnesemia due to HNF1beta mutation – This condition is characterized by low levels of magnesium in the blood, resulting from a mutation in the HNF1beta gene. The mutation affects the kidneys’ ability to reabsorb magnesium, leading to its excessive loss in urine. Patients may experience symptoms such as muscle cramps, weakness, and fatigue due to the deficiency of magnesium. Over time, the persistent low magnesium levels can impact various bodily functions, as magnesium is crucial for nerve and muscle function, as well as bone health. The condition is considered rare and can occur in both diabetic and non-diabetic individuals.

Trial ID:
2024-518855-43-00
Protocol code:
112930
Trial Phase:
Therapeutic confirmatory (Phase III)

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