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

ADPKD Clinical Trial

Official title:

Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02776241
• Other study ID #: HYDRA
• Status: Completed
• Phase: N/A
• First received: May 4, 2016
• Last updated: September 28, 2017
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: September 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ADPKD
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Other:
• water

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total kidney volume		Baseline and 3 hours
Secondary	Change in total cyst volume		Baseline and 3 hours
Secondary	Change in plasma renin		Baseline and 3 hours
Secondary	Change in plasma aldosterone		Baseline and 3 hours
Secondary	Change in plasma copeptin		Baseline and 3 hours