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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: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02776241
Date of registration: 04/05/2016
Prospective Registration: No
Primary sponsor: Rigshospitalet, Denmark
Public title: Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease
Scientific title: Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study
Date of first enrolment: September 2015
Target sample size: 40
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02776241
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
Denmark
Contacts
Name:     Signe V Naver, MD
Address: 
Telephone:
Email:
Affiliation:  Rigshospitalet, Denmark
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
ADPKD
Intervention(s)
Other: water
Primary Outcome(s)
Change in total kidney volume [Time Frame: Baseline and 3 hours]
Secondary Outcome(s)
Change in total cyst volume [Time Frame: Baseline and 3 hours]
Change in plasma aldosterone [Time Frame: Baseline and 3 hours]
Change in plasma copeptin [Time Frame: Baseline and 3 hours]
Change in plasma renin [Time Frame: Baseline and 3 hours]
Secondary ID(s)
HYDRA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Aarhus University Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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