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

Kyorin University

Status: Completed

Conditions: Disease Progression; Autosomal Dominant Polycystic Kidney Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01348035

KYR-003-PKD

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 30 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 2 patient groups

Water Load Group

Description:

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

Description:

Non-water load group: The patients are free to access water intake, as they like.