Efficacy Study of Water Drinking on PKD Progression. (ESWP)
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Purpose
Increased water intake slows autosomal dominant polycystic kidney disease (ADPKD) progression in animal models, but clinical implication is unknown. Encouraged water intake in patients with ADPKD for one year resulted in accelerated kidney enlargement and functional deterioration. Increased urine sodium and/or unknown factors concurrent with increased urine volume might stimulate disease progression more strongly than decrease in plasma vasopressin ameliorated it.
| 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
Urine
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The patients who visit Kyorin University Hospital.
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
No publications provided
| 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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Disease Progression Kidney Diseases Multicystic Dysplastic Kidney Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Congenital Abnormalities |
Disease Attributes Kidney Diseases, Cystic Pathologic Processes Urogenital Abnormalities Urologic Diseases |
ClinicalTrials.gov processed this record on March 02, 2015