Ongoing Clinical Trials for Congenital Nephrogenic Diabetes Insipidus
There is currently 1 ongoing clinical trial for congenital nephrogenic diabetes insipidus, a rare genetic condition where the kidneys cannot properly concentrate urine. This trial is investigating whether fluconazole, a medication traditionally used for fungal infections, could help reduce excessive urination and improve quality of life for patients with this condition.
Clinical trial locations
Study of Fluconazole Treatment for Patients with Congenital Nephrogenic Diabetes Insipidus
This clinical trial is taking place in Denmark and focuses on testing whether fluconazole can help people living with nephrogenic diabetes insipidus caused by mutations in the AVPR2 gene. This is a rare condition that affects the kidneys’ ability to concentrate urine, resulting in excessive urination and constant thirst that can significantly impact daily life.
Inclusion criteria: This study is recruiting male participants who are over 18 years old. To be eligible, you must have a confirmed diagnosis of nephrogenic diabetes insipidus through genetic testing showing a mutation in the AVPR2 gene. You need to be mentally capable of understanding the study procedures and providing informed consent. The study requires that you can follow instructions and are not part of vulnerable populations such as prisoners or individuals with mental disabilities.
Exclusion criteria: The study cannot include males younger than 18 or older than 65 years of age. Female patients are excluded as the study is designed specifically for male participants. You cannot participate if you do not have a confirmed AVPR2 gene mutation, if you are currently taking medications that might interact with fluconazole, or if you have severe liver or kidney problems unrelated to nephrogenic diabetes insipidus. Patients with allergies to fluconazole or similar antifungal medications, those unable to provide informed consent, those participating in other clinical trials, or those with uncontrolled heart conditions are also excluded.
Focus and goal: The main goal of this trial is to determine whether fluconazole can reduce the amount of urine produced and improve the body’s ability to concentrate urine in patients with this condition. Researchers will monitor daily urine volume and measure how concentrated the urine is through a test called osmolality. Additional measurements include blood tests to check salt levels and other substances, tracking how frequently participants need to urinate, analyzing urine samples for specific proteins, and measuring blood hormone levels. The treatment period lasts for 3 days, during which patients will receive fluconazole taken by mouth at doses up to 400 milligrams per day. The study aims to understand if this approach can improve quality of life and reduce the severe symptoms associated with nephrogenic diabetes insipidus.
Investigational drug: Fluconazole is an antifungal medication commonly used to treat fungal infections. In this trial, it is being investigated for a completely new purpose: helping to reduce excessive urination and improve urine concentration in patients with nephrogenic diabetes insipidus. While fluconazole is well-established for treating infections, researchers are exploring whether it might also help the kidneys better respond to water-retaining signals, potentially offering a new treatment option for this rare genetic condition.
Summary
Currently, there is only one active clinical trial available for patients with congenital nephrogenic diabetes insipidus. This trial is being conducted in Denmark and represents an innovative approach by investigating fluconazole, a medication not traditionally associated with kidney disorders, for treating this rare genetic condition. The study is specifically focused on patients with AVPR2 gene mutations and is limited to male participants over 18 years of age. While the number of trials is limited, this research could potentially open new treatment pathways for a condition that has few therapeutic options. Patients interested in participating should note the specific genetic testing requirements and the short 3-day treatment period involved in this study.
