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