Efficacy Study of Water Drinking on PKD Progression.

Kyorin University30 enrolled

Overview

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.

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

Conditions

Autosomal Dominant Polycystic Kidney Disease Disease Progression

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Urology, Kyorin University Hospital

Mitaka, Tokyo, Japan

Outcomes

Primary Outcomes

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

The relationship between urine volume (and urine osmolality) and change of TKV. TKV slopes are compared between pre-study and study period.

Time frame: One year (12 months) and pre-study period.

Secondary Outcomes

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

The relationship between urine volume (and urine osmolality) and change of GFR.

Time frame: One year (12 months)

Plasma arginine vasopressin (AVP, Copeptin) level.

The relationship between urine volume (osmolality) and plasma AVP.

Time frame: 4-8-12 months

Quality of life (QOL) questionnaire.

The relationship between QOL and urine volume.

Time frame: 4-8-12 months

Data from ClinicalTrials.gov

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