Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Effect of dapagliflozin on serum magnesium in HNF1ß patients with renal hypomagnesemia

This research study is investigating a new way to help people who have low magnesium levels in their blood because of a specific genetic condition called an HNF1beta mutation. This condition can affect how the kidneys handle magnesium, leading to health problems. The study is testing a medication called dapagliflozin. Researchers want to see if taking dapagliflozin can help raise magnesium levels in the blood. Some participants will receive the active medicine, while others will receive a placebo (a dummy pill with no active ingredient) to compare the effects. This is a crucial step to see if this treatment could benefit patients in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

22 Nov 2024

Hypomagnesemia due to HNF1beta mutation

What is this study about?

You might be interested in this study if you have a condition called an HNF1beta mutation, which is a genetic change that can affect your body's plumbing system, particularly your kidneys. One common issue with this mutation is that your kidneys might not hold onto magnesium as well as they should, leading to low magnesium levels in your blood. This is called renal hypomagnesemia.

Low magnesium can cause various problems, like muscle cramps, tiredness, or even more serious heart issues. Currently, treatments often involve taking magnesium supplements. This study is exploring if a different type of medicine, called dapagliflozin, could help your kidneys keep more magnesium in your body, thereby increasing your blood magnesium levels.

Dapagliflozin is a medicine already used for other conditions, but researchers want to see if it specifically helps with magnesium levels in HNF1beta patients. By comparing it to a placebo (a dummy pill), we can see if any changes are truly due to the medicine or something else. The findings from this study could potentially offer a new or better way to manage low magnesium in people with an HNF1beta mutation.

Key takeaways

The study is for adults with low magnesium due to an HNF1beta genetic mutation.
It tests if dapagliflozin medicine can increase magnesium levels.
Some participants get the active medicine, others a placebo.
Participation involves regular clinic visits for tests and monitoring.
Potential benefits include improved magnesium levels; risks involve possible side effects.
You can leave the study at any time.

Who may be eligible?

This study is for adults aged 18 years and older. Your gender doesn't matter for this study – both men and women can take part.

The main thing is that you must have low magnesium in your blood specifically because of an HNF1beta genetic mutation. The study team will need to confirm this with your medical history and possibly some tests.

They will also check other aspects of your health to make sure the study medication is safe for you. If you have any other serious health conditions or are taking certain medicines, you might not be able to join, but the study team will discuss all of this with you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with an HNF1beta genetic mutation?
Do you have low magnesium levels in your blood because of that mutation?
Are you willing and able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to either receive the study medicine (dapagliflozin) or a placebo (a dummy pill with no active drug). You wouldn't know which one you're getting, and neither would the study team, to keep the results fair.

You would need to attend several appointments at the study clinic. These visits would involve having blood tests to check your magnesium levels and other health markers, urine tests, and possibly physical exams to monitor your health. You would take the assigned study medication regularly as instructed by the doctors. The total time you would be in the study, from your first visit to your last follow-up, will be explained in detail by the study team, but these types of studies typically involve several months of participation, including regular check-ups.

Potential risks and benefits

Taking part in this study could potentially help improve your magnesium levels, which might reduce symptoms related to low magnesium. However, there's no guarantee the treatment will work for you, as some participants will receive a placebo. Like all medicines, dapagliflozin can have side effects, which the study team will explain fully. These might include increased urination, thirst, or a small risk of other issues. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is an HNF1beta mutation?

It's a change in a specific gene that can affect how your kidneys work, sometimes leading to low magnesium levels.

What does 'renal hypomagnesemia' mean?

It means your kidneys aren't holding onto enough magnesium, causing low magnesium levels in your blood.

What is dapagliflozin?

It's a medicine that researchers are testing to see if it can help increase magnesium levels in people with an HNF1beta mutation.

What is a placebo?

It's a 'dummy pill' that looks like the real medicine but contains no active drug, used for comparison in studies.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study team will know during the study to ensure the results are unbiased. This is called 'blinding'.