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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 October 2023 |
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Main ID: |
NCT03102632 |
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Date of registration:
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27/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease
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Scientific title:
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A Clinical Trial of Water Therapy for Autosomal Dominant Polycystic Kidney Disease |
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Date of first enrolment:
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June 1, 2017 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03102632 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Martin Prince, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- pre-existing diagnosis of Autosomal Dominant Polycystic Kidney Disease
- estimated glomerular filtration rate of 40 ml/min or greater
- urine osmolality > 400 mOsm/L
Exclusion Criteria:
- estimated glomerular filtration rate less than 40 ml/min
- low blood sodium levels
- syndrome of inappropriate diuretic hormone
- use of thiazide diuretics or selective serotonin reuptake inhibitors (SSRIs)
- use of tolvaptan, another vasopressin receptor antagonist, vasopressin agonists or
dDAVP
- contraindications to magnetic resonance imaging (MRI) (pacemakers, defibrillators,
implanted electronic devices, metallic foreign body)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Autosomal Dominant Polycystic Kidney
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Intervention(s)
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Other: High Water Intake
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Primary Outcome(s)
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Change in total kidney volume, as measured from magnetic resonance imaging
[Time Frame: 18 months]
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Secondary Outcome(s)
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Change in urine and blood markers of response to high water intake
[Time Frame: 18 months.]
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Kidney function change
[Time Frame: 18 months]
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Secondary ID(s)
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1701017921
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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