None listed
Conditions
Interventions
None listed
Sponsors
Hallym University Medical Center-Kangnam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged 18 and above - Patients falling under CKD stage 2-3 at the first administration and patients with rapidly progressing ADPKD (Mayo class 1C, 1D, and 1E) who took tolvaptan for the first time to delay cyst formation and the decline in kidney function - Subjects with kidney function test results checked at least twice over at least one year prior to tolvaptan treatment
Exclusion criteria
Exclusion criteria: - Patients took or is taking an investigational product in an ADPKD-related drug interventional study within 6 months prior to enrollment in this study - If it is difficult to use tolvaptan due to pregnancy, childbirth, breastfeeding, etc. - If it is difficult to take scans for radiological examinations (CT) to measure the effect of tolvaptan - Patients with severe renal impairment (e.g., Patients with currently active glomerulonephritis, kidney cancer, having a single kidney, history of renal surgery within the last 3 years, etc.) - Patients with severe hepatic impairments (e.g., Cirrhosis, viral hepatitis, unspecified liver function test abnormalities (ALT or AST > 3 x ULN or total bilirubin > 2 x ULN, etc.), etc.) - Patients with hyponatremia or hypernatremia - Patients with anuria - Patients with volume depletion - Patients who are unable to sense or appropriately respond to thirst - Patients who do not give their consent to participate in the study - Patients deemed ineligible to participate in this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the height-adjusted total kidne volume | — |
Secondary
| Measure | Time frame |
|---|---|
| change rate in the eGFR slope before/after tolvaptan administration;change rate in the htTLV slope before/after tolvaptan administration;Change in cardiac outcome (echoCG, EKG, BNP, BP);change rate in muscle mass before/after tolvaptan administration;Differences in patient-reported outcomes before/after tolvaptan treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactHayne Park
Hallym University Medical Center-Kangnam
Outcome results
None listed