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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eiji Higashihara, MD, Kyorin University
ClinicalTrials.gov Identifier:
NCT01348035
First received: May 3, 2011
Last updated: December 21, 2013
Last verified: May 2012
  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
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).

Resource links provided by NLM:


Further study details as provided by Kyorin University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

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
Study Population

The patients who visit Kyorin University Hospital.

Criteria

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 Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01348035

Locations
Japan
Department of Urology, Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611
Sponsors and Collaborators
Kyorin University
Investigators
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:
Autosomal Dominant Polycystic Kidney Disease.
Arginine vasopressin
Total Kidney Volume
Glomerular Filtration Rate

Additional relevant MeSH terms:
Kidney Diseases
Disease Progression
Polycystic Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Disease Attributes
Pathologic Processes
Kidney Diseases, Cystic
Urogenital Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 19, 2014