ESWP: Efficacy Study of Water Drinking on PKD Progression.

Sponsor

Kyorin University (Other)

Overall Status

Completed

CT.gov ID

NCT01348035

Collaborator

(none)

Enrollment

Location

21.1

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Disease Disease Progression

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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Apr 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.