Clinical Trial: Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
Brief Summary: The purpose of this research study is to determine if two investigational medications will be more effective in decreasing urine output than the currently available and routinely used medications in patients with congenital nephrogenic diabetes insipidus (NDI).
Detailed Summary:
The study involves the use of the investigational medications sildenafil and calcitonin. These medications have shown promise as treatment for NDI in laboratory (non-human) studies but have not been used for treatment of NDI in humans. At this time, there is no guarantee that these investigational medications will provide additional benefit to people with NDI.
The study is open to males, between the ages of 5 and 25 years who have been diagnosed with Nephrogenic diabetes insipidus (NDI) and who have normal kidney and bladder function. A total of 40 patients with NDI will be enrolled in the study. The study will involve two outpatient clinic visits, followed by a 9-night hospital stay, followed by a final follow-up outpatient clinic visit. All visits will take place within a 20-day time period.
At the first clinic visit, blood and urine testing for kidney and liver function and blood count will be performed. If the genetic alteration which causes your NDI has not been previously identified, blood for DNA testing will also be obtained. If a kidney and bladder ultrasound has not been performed in the past 6 months, it will be obtained. The ultrasound is to make sure that there is no problem with drainage of urine from the kidneys and bladder. You will be asked to fill out food preference questionnaires to use for planning of meals for the hospital stay. You will be given containers to collect two consecutive 24-hour urine samples at home. These urine collections will help determine how well your routine medicines are working to control your NDI.
At the second clinic visit, you will bring in the two 24-hour urine samples. Blood will again be collected for further testing of kidney function. You will be given containers to collect another 24-hour urine just prior to the hospital
Sponsor: University of Colorado, Denver
Current Primary Outcome: Urine volume [ Time Frame: 24-hour ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Frequency of urination [ Time Frame: 24-hour ]
- Urine osmolality [ Time Frame: 24-hour ]
Original Secondary Outcome: Same as current
Information By: University of Colorado, Denver
Dates:
Date Received: May 23, 2007
Date Started: May 2007
Date Completion:
Last Updated: December 19, 2012
Last Verified: October 2008
