Efficacy Study of Water Drinking on PKD Progression. (ESWP)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
| 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). |
- 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.
- 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.
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 |
|---|
|
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 20 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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 Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | May 3, 2011 |
| First Posted: | May 5, 2011 |
| Last Update Posted: | December 24, 2013 |
| Last Verified: | May 2012 |
Keywords provided by Eiji Higashihara, MD, 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 Polycystic Kidney, Autosomal Dominant Urologic Diseases Disease Attributes |
Pathologic Processes Kidney Diseases, Cystic Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn |