Autosomal dominant polycystic kidney disease (ADPKD)
Conditions
Interventions
investigational material(s)
Generic name etc : Tolvaptan
INN of investigational material :
Therapeutic category code : 249 Other hormone preparations (including antihormone preparations)
Dosage and A
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed. 2) Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251. 3) Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.
Exclusion criteria
Exclusion criteria: 1) Patients with eGFR of less than 15 mL/min/1.73 m2 2) Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant 3) Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan 4) Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG Every 1, 3 or 12 months combined renal volume (right and left kidneys) and renal function test Every 3 or 12 months | — |
Outcome results
None listed