Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Treatment of congenital nephrogenic diabetes insipidus with fluconazole, an antifungal medication

This research study is investigating a new use for an existing medicine called fluconazole. Fluconazole is commonly used to treat fungal infections, but we're exploring if it can help men who have a condition called nephrogenic diabetes insipidus. This condition means the kidneys can't properly control how much water leaves the body, leading to a lot of dilute urine. In this study, we're particularly interested in men aged 18 and older. We want to find out if taking fluconazole can help them pass less urine and make their urine more concentrated. This is a Phase II study, meaning it's an early look at whether the treatment shows promise.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Odense University Hospital

Enrolment target

Start

12 Sep 2024

Nephrogenic diabetes insipidus

What is this study about?

This study is about a kidney problem called nephrogenic diabetes insipidus. If you have this condition, your kidneys don't work properly to hold onto water, meaning you pass a lot of very watery urine. This can be disruptive in daily life as you constantly need to drink and urinate. We're looking into whether a medicine called fluconazole, which is typically used to treat fungal infections, could help. We believe it might help your kidneys work better to reabsorb water, making you urinate less often and with more concentrated urine.

The main goal of our study is to see if fluconazole helps reduce the amount of urine people pass and improves their body's ability to make their urine more concentrated. We'll be measuring these things carefully. We'll also be checking other things in your blood, like your body's water balance and certain hormones that control how your kidneys work, and looking at special markers in your urine.

Finding a new treatment for nephrogenic diabetes insipidus could make a big difference to people's lives. Living with this condition can be challenging, so discovering a medicine that helps the kidneys work more normally could lead to a better quality of life.

Key takeaways

The study tests fluconazole for a kidney problem called nephrogenic diabetes insipidus.
It aims to see if men can pass less urine and concentrate it better.
Participation involves taking medication and having regular check-ups.
It's a Phase II study, an early look at how effective the treatment might be.
You can stop participating at any time.

Who may be eligible?

To be part of this study, you need to be a man aged 18 years or older. This study is specifically looking at adult men who have been diagnosed with nephrogenic diabetes insipidus.

We would not be able to include women or anyone under the age of 18 in this particular study. There might also be other health conditions or medications you are taking that would mean you can't join this specific trial, but these would be discussed with the study team.

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 a man?
Are you 18 years old or older?
Have you been diagnosed with nephrogenic diabetes insipidus?
Are you willing to take the study medication (fluconazole)?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the fluconazole medication. We would then monitor you closely over a period. This would involve regular visits to the clinic where we would collect urine samples to measure how much urine you are passing and how concentrated it is. We would also take blood samples to check various levels, including your general body water balance and certain hormones.

You would also be asked to keep track of how often you urinate. The study will last for a certain amount of time, and all the assessments will be scheduled throughout that period. The research team will explain the full schedule of visits and what each visit involves before you make any decisions.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that fluconazole might help your nephrogenic diabetes insipidus by reducing how much you urinate and helping your kidneys concentrate urine better. However, there's no guarantee it will help you personally. Like all medicines, fluconazole can have side effects, which the study team will explain in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your 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
Denmark

Common questions

What is nephrogenic diabetes insipidus?

It's a kidney problem where your kidneys can't properly control how much water leaves your body, making you pass a lot of watery urine and feel very thirsty.

What is fluconazole?

Fluconazole is a medicine usually given to treat fungal infections. In this study, we're exploring if it has a different use for kidney problems.

Will taking part definitely help me?

We hope the treatment might help, but there's no guarantee. This is a research study to find out if it works and is safe for this condition.

Will I have to pay to join the study?

No, you will not have to pay to take part in the study. All study-related medication and tests are provided as part of the research.

Can women join this study?

No, this specific study is only open to men aged 18 and older.

How to find out more

Official trial record

Always speak to your GP or specialist before deciding to take part in a study.