Efficacy Study of Water Drinking on PKD Progression.

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease; Disease Progression

• Registration Number: NCT01348035
• Lead Sponsor: Kyorin University

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-05-03
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Primary Completion: 2012-11
• Study Completion: 2013-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Urology, Kyorin University Hospital; 🇯🇵 Mitaka, Tokyo, Japan