Efficacy Study of Water Drinking on PKD Progression. (ESWP)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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

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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 :	April 2011
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	January 2013

Groups and Cohorts

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Group/Cohort
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

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Primary Outcome Measures :

1. Total kidney volume (TKV) measured by magnetic resonance imaging (MRI). [ Time Frame: 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 :

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

Biospecimen Retention:   Samples Without DNA

Urine

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The patients who visit Kyorin University Hospital.

Criteria

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.

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
Department of Urology, Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611

Sponsors and Collaborators

Kyorin University

Investigators

Principal Investigator:	Eiji Higashihara, M.D.	Kyorin University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Eiji Higashihara, MD, Professor, Kyorin University
ClinicalTrials.gov Identifier:	NCT01348035 History of Changes
Other Study ID Numbers:	KYR-003-PKD
First Posted:	May 5, 2011
Last Update Posted:	March 15, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Eiji Higashihara, MD, Kyorin University:

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

Additional relevant MeSH terms:

Kidney Diseases; Disease Progression; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Urologic Diseases; Disease Attributes	Pathologic Processes; Kidney Diseases, Cystic; Abnormalities, Multiple; Congenital Abnormalities; Genetic Diseases, Inborn