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 : December 24, 2013
|Condition or disease|
|Autosomal Dominant Polycystic Kidney Disease. Disease Progression|
Abstract Background Increased water intake slows autosomal dominant polycystic kidney disease (ADPKD) progression in animal models, but clinical implication of this finding is unknown.
Methods The prospective one-year study was conducted on 34 ADPKD patients with creatinine clearance≧50 ml/min/1.73m2. Prior to the enrollment, 30 patients annually evaluated TKV and 24-hour urine for more than one year. Patients were divided into high (H-, n = 18) and free (F-, n = 16) water-intake groups. Total kidney volume (TKV) was measured at the beginning and end of the study. Twenty-four-hour urine and blood were analyzed every four months.
Results Prior to the study, urine volume (UV) in H-group was higher (P = 0.034), but pertinent data including TKV and kidney function slopes were not significantly different between two groups. During the study, UV further increased (P <0.001) in H-group but not in F-group. Plasma copeptin was lower (P = 0.024) in H-group than in F-group. Kidney function and TKV slopes became worse in H-group (P = 0.011 and 0.047, respectively) but not in F-group. High UV associated with increased urine sodium (UNa) and rapid decrease in eGFR(Eqcr-cys) (MDRD equation with cystatin C incorporated) (P = 0.043). UNa positively correlated with % increase in TKV (P = 0.014) and plasma copeptin weakly with increase in TKV (P = 0.038), respectively.
Conclusions Although statistical significance was not reached, high water intake appeared to accelerate rather than prevent disease progression, and these findings necessitate a long-term randomized study before drawing a final conclusion.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Observational Model:||Case Control|
|Official Title:||Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).|
|Study Start Date :||April 2011|
|Primary Completion Date :||November 2012|
|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|