A longitudinal clinical study to investigate the changes before and after administration of tolvaptan in patients whose clinical course is monitored prior to the approval of tolvaptan will employ a method different from that used in the TEMPO study.
- Patients who have started or will start receiving tolvaptan at Kyorin University Hospital.
- Patients whose use of Samsca complies with the criteria specified by the Ministry of Health, Labour and Welfare.
- TKV ≥ 750 mL.
- The increase in total renal capacity ≥ approximately 5%/year.
- Patients who have given signed consent to the examination protocol, which includes hospitalization at the initiation of tolvaptan treatment (i.e. examination/educational hospitalization for the first 3 days. Monthly blood tests at the time of ambulatory visits, 24-hour urine collection every 6 months, annual TKV measurement by MRI and inulin clearance measurement)
- Patients for whom the baseline TKV and eGFR percent change is available.
- Patients from whom freely given, written informed consent to participate in the study has been obtained.
- Patients who do not consent to participation in the study, or those who later withdraw their consent.
- Patients who have been taking tolvaptan since the TEMPO study.
- Patients who are not eligible at our hospital to take tolvaptan for the stated indication based on the criteria for careful administration of Samsca as specified by the Ministry of Health, Labour and Welfare.
- Pediatric patients ≤ 15 years.
- Patients with a history of hypersensitivity to tolvaptan or similar chemical compounds.
- Patients who do not feel thirsty or have difficulty swallowing water.
- Patients with hypernatremia.
- Patients with eGFR < 15 mL/min/1.73 m2.
- Patients with chronic hepatitis, drug-induced hepatic dysfunction, and other hepatic dysfunctions.
- Pregnant women or women suspected of being pregnant. Female patients who wish to become pregnant.
Eiji Higashihara, MD