Testing NDI-5001 for X-linked Nephrogenic Diabetes Insipidus
Part of Hormones & metabolism, Kidney & urinary, Women’s health & pregnancy clinical trials.
This study tests a new drug called NDI-5001 in adult men with a specific genetic form of nephrogenic diabetes insipidus (a condition where the kidneys cannot concentrate urine properly). The trial checks whether the drug is safe, how your body handles it, and whether it might help reduce excessive urination and thirst.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You are an adult male with confirmed X-linked congenital nephrogenic diabetes insipidus caused by a mutation in the AVPR2 gene
- Your kidneys produce very dilute urine (urine osmolality of 200 mOsm/kg or less, measured in morning samples before eating or drinking)
- Your BMI (body mass index) is between 18.0 and 32.0 kg/m²
- You have not taken any investigational (experimental) drugs in the 30 days before enrolling
- You have normal kidney function (estimated glomerular filtration rate of 60 mL/min/1.73m² or higher)
- You are willing to eat a low-sodium diet (no more than 1 gram of salt per day) during the in-clinic portion of the study
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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