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

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ClinicalTrials.gov Identifier: NCT01348035
Recruitment Status : Completed
First Posted : May 5, 2011
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Eiji Higashihara, MD, Kyorin University

May 3, 2011
May 5, 2011
March 15, 2018
April 2011
November 2012   (Final data collection date for primary outcome measure)
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.
Total Kidney Volume (TKV) measured by MRI and GFR estimated by plasma creatinine and cystatin C. Change rate (slope) of TKV and GFR. [ Time Frame: One year (12 months) ]
  • The relationship between urine volume (osmolality) and TKV (GFR).
  • The relationship between urine volume and TKV (GFR) slopes.
Complete list of historical versions of study NCT01348035 on ClinicalTrials.gov Archive Site
  • 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.
Plasma AVP (Copeptine) level and QOL questionnaire. [ Time Frame: every 4 months ]
  • The relationship between urine volume (osmolality) and plasma AVP.
  • The relationship between urine omolality and plasma osmolality.
  • The relationship between QOL and urine volume.
  • The relationship between plasma AVP and plasma copeptine level.
Not Provided
Not Provided
 
Efficacy Study of Water Drinking on PKD Progression.
Efficacy Study of Long-term Water Intake on the Progression of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD.
Tolvaptan was approved in Japan for the treatment of autosomal dominant polycystic kidney disease (ADPKD) in March 2014. This is a prospective 5-year study to compare the change in total kidney volume (TKV) before and after tolvaptan therapy, as the primary endpoint, in patients with ADPKD. Study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, March 31, 2018) and at 5 years (data cut-off, March 31, 2020)
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Urine
Non-Probability Sample
The patients who visit Kyorin University Hospital.
  • Autosomal Dominant Polycystic Kidney Disease
  • Disease Progression
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
January 2013
November 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01348035
KYR-003-PKD
No
Not Provided
Plan to Share IPD: No
Eiji Higashihara, MD, Kyorin University
Kyorin University
Not Provided
Principal Investigator: Eiji Higashihara, M.D. Kyorin University
Kyorin University
March 2018