Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney Disease

Not Applicable

Completed

• Conditions: ADPKD
• Interventions: Other: water

• Registration Number: NCT02776241
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-05-04
• Study First Submitted QC: 2016-05-17
• Study First Posted: 2016-05-18
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high water intake	water	20 patients will be subjected to 1 hour of high water intake (20 ml/kg) following MR scan of the kidneys.

Primary Outcome Measures

Name	Time	Method
Change in total kidney volume	Baseline and 3 hours

Secondary Outcome Measures

Name	Time	Method
Change in plasma renin	Baseline and 3 hours
Change in plasma aldosterone	Baseline and 3 hours
Change in plasma copeptin	Baseline and 3 hours
Change in total cyst volume	Baseline and 3 hours

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark