ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01348035
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Eiji Higashihara, MD, 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.

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 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

Resource links provided by the National Library of Medicine


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.



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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01348035


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

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    Key Record Dates
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