Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00478335
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2007-05-23
Brief Title:
Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Pharmacologic Treatment of Congenital Nephrogenic Diabetes Insipidus
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 Subjects will be asked to fill out food preference questionnaires to use for planning of meals for the hospital stay Subjects will be given containers to collect two consecutive 24-hour urine samples at home These urine collections will help determine how well the subjects routine medicines are working to control their NDI
At the second clinic visit subjects will bring in the two 24-hour urine samples Blood will again be collected for further testing of kidney function Subjects will be given containers to collect another 24-hour urine just prior to the hospital visit
The third visit requires hospital admission and will be scheduled at the study site closest to the subjects home The Childrens Hospital Denver Colorado University of Aarhus Denmark For the hospital visit subjects will need to stop their usual NDI medications for 48 hours prior to the visit Subjects will perform another 24-hour urine collection on the day prior to your hospital admission This urine sample will be turned in to the laboratory when you are admitted to the hospital for the research study The length of the hospital stay is 10 days9 nights During the stay subjects can expect to have their weight heart rate and blood pressure checked three times a day All urine will be collected Blood testing will be performed every other day Subjects will need to eat the meals provided at the hospital all meals will be provided according to a low-salt diet restriction Subjects may drink fluids as desired but they will need to avoid caffeine-containing beverages and alcohol
On the first day of the hospital stay testing will be performed to confirm the diagnosis of NDI This test involves administration of the medicine dDAVP Desmopressin through an IV catheter into a vein with collection of urine every 30 minutes for 4 hours subjects will be randomized like the toss of a coin to receive either the investigational medication treatment for 4 days followed by the routine medication treatment for 4 days or vice versa When subjects receive the routine medication treatment they will receive placebos inactive substances like a sugar pill in place of the investigational medicines In this way neither the subject nor the investigator will know whether the subjects are receiving the investigational or the routine medication treatment first Medicines will be given twice a day during the hospital stay On the last day of the hospital stay subjects will be instructed to resume their normal diet and medications
At a final outpatient clinic visit blood testing and urinalysis will be performed
Potential benefits of participation include a no-cost health examination laboratory studies and an evaluation of current management of NDI There is no cost for participation in this research study No pay will be given to participants in this research study
This research study has been approved by the ethical review boards of the following institutions Colorado Multiple Institutional Review Board 06-0588 Emory University Institutional Review Board 729-2005 and the University of Aarhus 20050183 Individuals who decide to take part in this research study will need to sign a specific consent form at a participating institution as well as a release for use of personal health information HIPAA form
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 Subjects will be asked to fill out food preference questionnaires to use for planning of meals for the hospital stay Subjects will be given containers to collect two consecutive 24-hour urine samples at home These urine collections will help determine how well the subjects routine medicines are working to control their NDI
At the second clinic visit subjects will bring in the two 24-hour urine samples Blood will again be collected for further testing of kidney function Subjects will be given containers to collect another 24-hour urine just prior to the hospital visit
The third visit requires hospital admission and will be scheduled at the study site closest to the subjects home The Childrens Hospital Denver Colorado University of Aarhus Denmark For the hospital visit subjects will need to stop their usual NDI medications for 48 hours prior to the visit Subjects will perform another 24-hour urine collection on the day prior to your hospital admission This urine sample will be turned in to the laboratory when you are admitted to the hospital for the research study The length of the hospital stay is 10 days9 nights During the stay subjects can expect to have their weight heart rate and blood pressure checked three times a day All urine will be collected Blood testing will be performed every other day Subjects will need to eat the meals provided at the hospital all meals will be provided according to a low-salt diet restriction Subjects may drink fluids as desired but they will need to avoid caffeine-containing beverages and alcohol
On the first day of the hospital stay testing will be performed to confirm the diagnosis of NDI This test involves administration of the medicine dDAVP Desmopressin through an IV catheter into a vein with collection of urine every 30 minutes for 4 hours subjects will be randomized like the toss of a coin to receive either the investigational medication treatment for 4 days followed by the routine medication treatment for 4 days or vice versa When subjects receive the routine medication treatment they will receive placebos inactive substances like a sugar pill in place of the investigational medicines In this way neither the subject nor the investigator will know whether the subjects are receiving the investigational or the routine medication treatment first Medicines will be given twice a day during the hospital stay On the last day of the hospital stay subjects will be instructed to resume their normal diet and medications
At a final outpatient clinic visit blood testing and urinalysis will be performed
Potential benefits of participation include a no-cost health examination laboratory studies and an evaluation of current management of NDI There is no cost for participation in this research study No pay will be given to participants in this research study
This research study has been approved by the ethical review boards of the following institutions Colorado Multiple Institutional Review Board 06-0588 Emory University Institutional Review Board 729-2005 and the University of Aarhus 20050183 Individuals who decide to take part in this research study will need to sign a specific consent form at a participating institution as well as a release for use of personal health information HIPAA form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None