- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02776241
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease
September 28, 2017 updated by: Signe Vinsand Naver, Rigshospitalet, Denmark
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study
The objective of this study is to measure the influence of both short term water restriction and high water intake on total kidney volume, measured by Magnetic Resonance Imaging (MRI) scan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients.
Study Overview
Detailed Description
Patients will be randomized to either water restriction for 3 hours or high water intake (20 ml/kg) for 1 hour.
Before intervention and after intervention patients will have an MRI scan of the kidneys to measure the total kidney volume (TKV) (differentiated in cortex, medulla and cyst volume).
The objective is to identify whether water restriction or high water load will change the TKV.
Secondly investigators will analyze different biomarkers (aldosterone, renin, vasopressin/copeptin, urine- and blood-osmolarity) before and after the intervention.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, 2100
- Rigshospitalet
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: water restriction
20 patients will be subjected to 3 hours of water restriction following MR scan of the kidneys.
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Active Comparator: high water intake
20 patients will be subjected to 1 hour of high water intake (20 ml/kg) following MR scan of the kidneys.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in total kidney volume
Time Frame: Baseline and 3 hours
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Baseline and 3 hours
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in total cyst volume
Time Frame: Baseline and 3 hours
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Baseline and 3 hours
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Change in plasma renin
Time Frame: Baseline and 3 hours
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Baseline and 3 hours
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Change in plasma aldosterone
Time Frame: Baseline and 3 hours
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Baseline and 3 hours
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Change in plasma copeptin
Time Frame: Baseline and 3 hours
|
Baseline and 3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Signe V Naver, MD, Rigshospitalet, Denmark
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
May 4, 2016
First Submitted That Met QC Criteria
May 17, 2016
First Posted (Estimate)
May 18, 2016
Study Record Updates
Last Update Posted (Actual)
October 2, 2017
Last Update Submitted That Met QC Criteria
September 28, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HYDRA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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