Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease
Primary Purpose
ADPKD
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
water
Sponsored by
About this trial
This is an interventional diagnostic trial for ADPKD focused on measuring ADPKD, total kidney volume, kidney disease
Eligibility 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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
water restriction
high water intake
Arm Description
20 patients will be subjected to 3 hours of water restriction following MR scan of the kidneys.
20 patients will be subjected to 1 hour of high water intake (20 ml/kg) following MR scan of the kidneys.
Outcomes
Primary Outcome Measures
Change in total kidney volume
Secondary Outcome Measures
Change in total cyst volume
Change in plasma renin
Change in plasma aldosterone
Change in plasma copeptin
Full Information
NCT ID
NCT02776241
First Posted
May 4, 2016
Last Updated
September 28, 2017
Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02776241
Brief Title
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease
Official Title
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADPKD
Keywords
ADPKD, total kidney volume, kidney disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
water restriction
Arm Type
No Intervention
Arm Description
20 patients will be subjected to 3 hours of water restriction following MR scan of the kidneys.
Arm Title
high water intake
Arm Type
Active Comparator
Arm Description
20 patients will be subjected to 1 hour of high water intake (20 ml/kg) following MR scan of the kidneys.
Intervention Type
Other
Intervention Name(s)
water
Primary Outcome Measure Information:
Title
Change in total kidney volume
Time Frame
Baseline and 3 hours
Secondary Outcome Measure Information:
Title
Change in total cyst volume
Time Frame
Baseline and 3 hours
Title
Change in plasma renin
Time Frame
Baseline and 3 hours
Title
Change in plasma aldosterone
Time Frame
Baseline and 3 hours
Title
Change in plasma copeptin
Time Frame
Baseline and 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe V Naver, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease
We'll reach out to this number within 24 hrs