Autosomal Dominant Polycystic Kidney Disease
Conditions
Interventions
None listed
Sponsors
Autosomal Dominant Polycystic Kidney Disease Research Section, Kyorin University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over the age of 18 who started or will start tolvaptan therapy at Kyorin University Hospital 2) Patients who meet the criteria for the use of Samsca specified by the Ministry of Health, Labour and Welfare - TKV :750 ml or more - TKV slope : approximately 5percent per year or more 3) Patients for whom the TKV and eGFR (percent change) data before the start of tolvaptan therapy are available 4) Patients who freely provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Patients who have been taking tolvaptan since the TEMPO study 2) Patients who are not eligible, at the discretion of Kyorin University Hospital, to take tolvaptan for the stated indication according to the criteria for careful administration of Samsca as specified by the Ministry of Health, Labour and Welfare - 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 less than 15 mL/min/1.73 m2 - Patients with chronic hepatitis, drug-induced hepatic dysfunction or other hepatic dysfunctions - Pregnant women or women suspected of being pregnant. Female patients who wish to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change in TKV volumetrically measured by MRI (% per year) will be compared before and after the start of tolvaptan therapy within each patient. The evaluation includes stratified analyses by patient background factors, examination data obtained during the therapy, etc. -Supplementary assessment of the primary outcome variable- Using the "a" as an indicator, the effect of tolvaptan on HtTKV slope will be supplementarily assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) The percent change in eGFR (mL/min/1.73 m2 per year) will be compared before and after tolvaptan therapy. The evaluation includes stratified analyses by patient background factors, observation/examination data obtained during the therapy, etc. 2) The safety of tolvaptan will be evaluated. Safety data will be reported to Otsuka Pharmaceutical Co., Ltd., as specified by the protocol. The evaluation includes stratified analyses by patient background factors, examination data obtained during the therapy, etc. 3) Based on the results of 24-hour urine collection, blood tests, inulin clearance, and TKV, the effects of or response to tolvaptan will be evaluated. The evaluation includes stratified analyses by patient background factors, examination data obtained during the therapy, etc. 4) Patients are required to be hospitalized for the first dose of tolvaptan. The results of 24-hour urine collection, and inulin clearance, and other data obtained during the hospitalization will be used to assess the clinical conditions of ADPKD , 5) The correlation between inulin clearance and eGFR estimated using different formulae will be investigated to elucidate the impact of tolvaptan on the correlation. 6) The association between the results of DNA analysis and the effect of tolvaptan will be analyzed. | — |
Countries
Japan
Contacts
Public ContactEiji Higashihara
Autosomal Dominant Polycystic Kidney Disease Research Section, Kyorin Univ., School of Med. urology
Outcome results
None listed