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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT02776241 |
Date of registration:
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04/05/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease
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Scientific title:
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Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study |
Date of first enrolment:
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September 2015 |
Target sample size:
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40 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02776241 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Signe V Naver, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Rigshospitalet, Denmark |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- ADPKD
- CKD stage 1-3
Exclusion Criteria:
- Patients treated with diuretics
- Pregnancy
- Change in antihypertensive treatment < 1 month
- Any condition contraindicating MR scan
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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ADPKD
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Intervention(s)
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Other: water
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Primary Outcome(s)
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Change in total kidney volume
[Time Frame: Baseline and 3 hours]
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Secondary Outcome(s)
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Change in total cyst volume
[Time Frame: Baseline and 3 hours]
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Change in plasma aldosterone
[Time Frame: Baseline and 3 hours]
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Change in plasma copeptin
[Time Frame: Baseline and 3 hours]
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Change in plasma renin
[Time Frame: Baseline and 3 hours]
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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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