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

May 3, 2011
December 21, 2013
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. ] [ 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.
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) ] [ Designated as safety issue: No ]
  • 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) ] [ 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.
Plasma AVP (Copeptine) level and QOL questionnaire. [ Time Frame: every 4 months ] [ Designated as safety issue: No ]
  • 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).

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.

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.

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
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.
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01348035
KYR-003-PKD
No
Eiji Higashihara, MD, Kyorin University
Kyorin University
Not Provided
Principal Investigator: Eiji Higashihara, M.D. Kyorin University
Kyorin University
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP