Amsterdam UMC
Amsterdam, The Netherlands
Not recruitingHypomagnesaemiaRare disease
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 trial about?
A plain-language summary of the goals, design and what participants do
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.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
4 criteria
- 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 trial?
10 criteria
- 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.
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Verified sites
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Responsive Responsive Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The NetherlandsVerified Stichting Radboud University Medical Center
Nijmegen, The Netherlands
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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.
What is already known about the treatment
Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied for its effects on serum magnesium levels in patients with renal hypomagnesemia due to HNF1beta mutation. The main therapeutic indication for dapagliflozin is to manage blood sugar levels in individuals with type 2 diabetes, but it is also being explored for its potential benefits in other conditions. At the molecular level, dapagliflozin works by inhibiting the sodium-glucose co-transporter 2 (SGLT2) in the kidneys, which reduces glucose reabsorption and increases glucose excretion in the urine. It is classified as an SGLT2 inhibitor in pharmacology.
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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518855-43-00Protocol code112930Estimated enrolment12 patientsSponsorStichting Radboud University Medical Center
sourced from the EU Clinical Trials Register and site verification
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