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
|Condition or disease|
|Autosomal Dominant Polycystic Kidney Disease Disease Progression|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|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|
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.
- 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
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
|Department of Urology, Kyorin University Hospital|
|Mitaka, Tokyo, Japan, 181-8611|
|Principal Investigator:||Eiji Higashihara, M.D.||Kyorin University|