Efficacy Study of Water Drinking on PKD Progression.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01348035

Acronym

ESWP

Enrollment

Registered

2011-05-05

Start date

2011-04-30

Completion date

2013-01-31

Last updated

2018-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal Dominant Polycystic Kidney Disease, Disease Progression

Keywords

Autosomal Dominant Polycystic Kidney Disease., Arginine vasopressin, Total Kidney Volume, Glomerular Filtration Rate

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)

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Japan

Outcome results