Efficacy Study of Water Drinking on PKD Progression. (ESWP)
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ClinicalTrials.gov Identifier: NCT01348035 |
Recruitment Status
:
Completed
First Posted
: May 5, 2011
Last Update Posted
: March 15, 2018
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Condition or disease |
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Autosomal Dominant Polycystic Kidney Disease Disease Progression |
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 |

Group/Cohort |
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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.
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Non-Water Loaded Group
Non-water load group: The patients are free to access water intake, as they like.
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- 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.
- 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.
- Plasma arginine vasopressin (AVP, Copeptin) level. [ Time Frame: 4-8-12 months ]The relationship between urine volume (osmolality) and plasma AVP.
- Quality of life (QOL) questionnaire. [ Time Frame: 4-8-12 months ]The relationship between QOL and urine volume.
Biospecimen Retention: Samples Without DNA

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

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