Study of Fluconazole Treatment for Patients with Congenital Nephrogenic Diabetes Insipidus

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What is this study about?

This clinical trial focuses on Nephrogenic Diabetes Insipidus, a rare condition where the kidneys cannot properly concentrate urine, leading to excessive urination and constant thirst. The study examines whether fluconazole, a medication typically used to treat fungal infections, can help reduce the amount of urine produced and improve the body’s ability to concentrate urine in people with this condition.

The treatment being studied involves using fluconazole taken by mouth, with doses up to 400 milligrams per day. The medication will be given to patients who have Nephrogenic Diabetes Insipidus specifically caused by changes in the AVPR2 gene. The study aims to find out if this medication can improve quality of life and reduce the severe symptoms that people with this condition experience.

During the study, researchers will monitor how much urine patients produce naturally and how well their bodies can concentrate this urine. They will also track other body measurements to understand how well the treatment is working. The treatment period lasts for 3 days, during which patients will receive the study medication.

1 Initial assessment

Your participation begins with confirmation of nephrogenic diabetes insipidus diagnosis through genetic testing of the AVPR2 gene.

A medical evaluation will be conducted to ensure you meet all participation criteria, including being male, over 18 years of age, and mentally capable of understanding the study procedures.

2 Treatment administration

You will receive fluconazole, an antifungal medication, taken by mouth.

The treatment aims to reduce urine production and improve your body’s ability to concentrate urine.

3 Primary measurements

Your daily urine volume will be measured.

The concentration of your urine (called osmolality) will be tested to check how well your kidneys are working.

4 Additional testing

Blood tests will measure salt levels and other substances in your blood.

The frequency of your urination will be recorded.

Urine samples will be analyzed for specific proteins.

Blood hormone levels will be measured.

5 Study duration

The study runs from September 2020 to September 2025.

Your individual participation timeline will be determined by the study doctor.

Who Can Join the Study?

Must be male
Must be over 18 years old
Must be able to understand and follow study instructions
Must have confirmed genetic defect in AVPR2 gene (a specific gene mutation that causes the body to not respond properly to a hormone that controls water balance)
Must have confirmed diagnosis of nephrogenic diabetes insipidus through genetic testing
Must be mentally capable of participating in the study and providing informed consent
Must not be part of any vulnerable populations (such as prisoners, mentally disabled persons, or other protected groups)

Who Cannot Join the Study?

Male patients younger than 18 years old or older than 65 years old
Female patients (the study is designed for male participants only)
Patients who do not have a confirmed AVPR2 gene mutation (a specific genetic change that causes the condition)
Patients who are currently taking medications that could interact with fluconazole (the study medication)
Patients with severe liver problems, as fluconazole is processed by the liver
Patients with severe kidney problems, except those related to nephrogenic diabetes insipidus
Patients who are allergic to fluconazole or similar antifungal medications
Patients who are unable to provide informed consent
Patients participating in other clinical trials
Patients with uncontrolled heart conditions

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.09.2020

Trial locations

Investigated drugs:

Clotrimazole

Fluconazole is an antifungal medication that is being studied as a potential treatment for nephrogenic diabetes insipidus (NDI). While it is commonly used to treat fungal infections, in this trial it is being investigated for its potential to help reduce excessive urination and improve the body’s ability to concentrate urine in patients with NDI. This new application of fluconazole could potentially help improve the quality of life for people who have this rare genetic condition affecting their kidneys.

Investigated diseases:

Congenital nephrogenic diabetes insipidus

Nephrogenic Diabetes Insipidus – A rare condition where the kidneys cannot properly concentrate urine, leading to excessive urination and constant thirst. The condition occurs when the kidneys fail to respond to a hormone called vasopressin that normally helps the body retain water. People with this condition produce large amounts of dilute urine, even when their body is trying to conserve water. The disorder can be inherited through genetic mutations, particularly in the AVPR2 gene. This condition typically manifests early in life with symptoms including frequent urination during both day and night, and an intense, persistent thirst.

Trial ID:

2024-517438-16-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Fluconazole Treatment for Patients with Congenital Nephrogenic Diabetes Insipidus

What is this study about?

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