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Completed

NCT Number: NCT02776241

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

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.

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Key information

Conditions

ADPKD Abnormalities, Multiple Ciliopathies Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Kidney Diseases Kidney Diseases, Cystic Male Urogenital Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Water

Other

Primary outcomes

  1. Change in total kidney volume

    Time frame: Baseline and 3 hours

Secondary outcomes

  1. Change in total cyst volume

    Time frame: Baseline and 3 hours

  2. Change in plasma renin

    Time frame: Baseline and 3 hours

  3. Change in plasma aldosterone

    Time frame: Baseline and 3 hours

  4. Change in plasma copeptin

    Time frame: Baseline and 3 hours

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Aarhus University Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 18, 2016
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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