Not recruitingRare disease

Study of Fluconazole Treatment for Patients with Congenital Nephrogenic Diabetes Insipidus

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

7 criteria

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 trial?

10 criteria

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

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Verified sites

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Odense University Hospital
Verified
Odense, Denmark

Trial locations

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Investigated drugs

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.

Clotrimazole

What is already known about the treatment

Fluconazole - An antifungal medication that is being investigated for a novel use in treating nephrogenic diabetes insipidus (NDI), particularly in cases caused by AVPR2 gene mutations. Typically administered orally in tablet form or through intravenous infusion, this medication is primarily known and approved worldwide for treating various fungal infections, but clinical trials are exploring its potential to reduce excessive urination and improve urine concentration in NDI patients. The drug belongs to the azole class of antifungal medications and works by inhibiting the synthesis of ergosterol, an essential component of fungal cell membranes, though its mechanism of action in treating NDI is being studied through clinical research to understand how it might affect water reabsorption in the kidneys.

Investigated diseases

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.