Efficacy Study of Water Drinking on PKD Progression.

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Brief Title

Efficacy Study of Water Drinking on PKD Progression.

Official Title

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

Brief Summary

      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.
    

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


Primary Outcome

Total kidney volume (TKV) measured by magnetic resonance imaging (MRI).

Secondary Outcome

 Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.

Condition

Autosomal Dominant Polycystic Kidney Disease


Study Arms / Comparison Groups

 Water Load Group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

30

Start Date

April 2011

Completion Date

January 2013

Primary Completion Date

November 2012

Eligibility Criteria

        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.
      

Gender

All

Ages

20 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Eiji Higashihara, M.D., , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT01348035

Organization ID

KYR-003-PKD


Responsible Party

Principal Investigator

Study Sponsor

Kyorin University


Study Sponsor

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


Verification Date

March 2018