NCT02776241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

May 4, 2016

Last Update Submit

September 28, 2017

Conditions

ADPKD

Keywords

ADPKDtotal kidney volumekidney disease

Outcome Measures

Primary Outcomes (1)

  • Change in total kidney volume

    Baseline and 3 hours

Secondary Outcomes (4)

  • Change in total cyst volume

    Baseline and 3 hours

  • Change in plasma renin

    Baseline and 3 hours

  • Change in plasma aldosterone

    Baseline and 3 hours

  • Change in plasma copeptin

    Baseline and 3 hours

Study Arms (2)

water restriction

NO INTERVENTION

20 patients will be subjected to 3 hours of water restriction following MR scan of the kidneys.

high water intake

ACTIVE COMPARATOR

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

Other: water

Interventions

waterOTHER
high water intake

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ADPKD
  • CKD stage 1-3

You may not qualify if:

  • Patients treated with diuretics
  • Pregnancy
  • Change in antihypertensive treatment \< 1 month
  • Any condition contraindicating MR scan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal DominantKidney Diseases

Interventions

Water

Condition Hierarchy (Ancestors)

Polycystic Kidney DiseasesKidney Diseases, CysticUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCiliopathiesGenetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Signe V Naver, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 4, 2016

First Posted

May 18, 2016

Study Start

September 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

Locations

DK(1)