Efficacy Study of Water Drinking on PKD Progression. (ESWP)
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Purpose
| Condition |
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Autosomal Dominant Polycystic Kidney Disease. Disease Progression |
| Study Type: | Observational |
| Study Design: | 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). |
- Total kidney volume (TKV) measured by magnetic resonance imaging (MRI). [ Time Frame: One year (12 months) and pre-study period. ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]The relationship between urine volume (and urine osmolality) and change of GFR.
- Plasma arginine vasopressin (AVP, Copeptin) level. [ Time Frame: 4-8-12 months ] [ Designated as safety issue: No ]The relationship between urine volume (osmolality) and plasma AVP.
- Quality of life (QOL) questionnaire. [ Time Frame: 4-8-12 months ] [ Designated as safety issue: No ]The relationship between QOL and urine volume.
Biospecimen Retention: Samples Without DNA
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2011 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01348035
| Japan | |
| Department of Urology, Kyorin University Hospital | |
| Mitaka, Tokyo, Japan, 181-8611 | |
| Principal Investigator: | Eiji Higashihara, M.D. | Kyorin University |
More Information
| Responsible Party: | Eiji Higashihara, MD, Professor, Kyorin University |
| ClinicalTrials.gov Identifier: | NCT01348035 History of Changes |
| Other Study ID Numbers: | KYR-003-PKD |
| Study First Received: | May 3, 2011 |
| Last Updated: | December 21, 2013 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Kyorin University:
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Autosomal Dominant Polycystic Kidney Disease. Arginine vasopressin Total Kidney Volume Glomerular Filtration Rate |
Additional relevant MeSH terms:
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Kidney Diseases Disease Progression Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant |
Urologic Diseases Disease Attributes Pathologic Processes Kidney Diseases, Cystic |
ClinicalTrials.gov processed this record on September 28, 2016