Efficacy Study of Water Drinking on PKD Progression.

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

— ESWP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348035
• Other study ID #: KYR-003-PKD
• Status: Completed
• Phase: N/A
• First received: May 3, 2011
• Last updated: March 14, 2018
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2018
• Source: Kyorin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Disease Progression
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Locations

Country	Name	City	State
Japan	Department of Urology, Kyorin University Hospital	Mitaka	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Kyorin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year (12 months) and pre-study period.
Secondary	Glomerular filtration rate (GFR) estimated by plasma creatinine and cystatin C.	The relationship between urine volume (and urine osmolality) and change of GFR.	One year (12 months)
Secondary	Plasma arginine vasopressin (AVP, Copeptin) level.	The relationship between urine volume (osmolality) and plasma AVP.	4-8-12 months
Secondary	Quality of life (QOL) questionnaire.	The relationship between QOL and urine volume.	4-8-12 months