Efficacy Study of Water Drinking on PKD Progression. (ESWP)

March 14, 2018 updated by: Eiji Higashihara, MD, Kyorin University

Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.

Study Overview

Status

Completed

Conditions

Detailed Description

Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Tokyo
      • Mitaka, Tokyo, Japan, 181-8611
        • Department of Urology, Kyorin University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients who visit Kyorin University Hospital.

Description

Inclusion Criteria:

  • The patients with ADPKD
  • The patients who consent to the study protocol
  • Estimated glomerular filtration rate (eGFR) or Creatinine Clearance greater than 50ml/min/1.73m2

Exclusion Criteria:

  • Patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders.
  • The patients who take habitual medication which affects the AVP action such as selective serotonin reuptake inhibitors (SSRI ), tricyclic antidepressants or diuretics.
  • The patients who is considered inappropriate by physicians.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Water Load Group
Water load group: 2.5 ~ 3 L water intake daily for 12 months (50ml/Kg body weight/day). When large amount water intake is not sustainable, patients can reduce the amount of water intake to the levels as much as large he or she can sustain.
Non-Water Loaded Group
Non-water load group: The patients are free to access water intake, as they like.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).
Time Frame: One year (12 months) and pre-study period.
The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period.
One year (12 months) and pre-study period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.
Time Frame: One year (12 months)
The relationship between urine volume (and urine osmolality) and change of GFR.
One year (12 months)
Plasma arginine vasopressin (AVP, Copeptin) level.
Time Frame: 4-8-12 months
The relationship between urine volume (osmolality) and plasma AVP.
4-8-12 months
Quality of life (QOL) questionnaire.
Time Frame: 4-8-12 months
The relationship between QOL and urine volume.
4-8-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyorin University

Investigators

  • Principal Investigator: Eiji Higashihara, M.D., Kyorin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 4, 2011

First Posted (ESTIMATE)

May 5, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYR-003-PKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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