Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD

156-402-00110

This is a Post-Marketing Surveillance study(PMS) of Samsca® tablets in actual use in cases to slow the progression of cyst development and renal insufficiency in accordance with Korean regulations on Risk Management Plan(RMP) and New Drug Re-examination. This survey is a post-marketing, prospective, single-arm, all-cases survey conducted on approved indication, usage, dosage.

2016-07-19

2025-11-01

2025-11-01

Recruiting

600

Inclusion Criteria: 1. 18 years and older patients with CKD(chronic kidney disease) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease. 2. Patients who need to be prescribed by Investigators who got registered in Risk Management Plan. 3. Patients who have agreed and signed on conditions specified in Risk Management Plan. Exclusion Criteria: 1. Patients with known or suspected hypersensitivity to tolvaptan or chemically related structures such as benzazepines or to any ingredient of the drug 2. Patients requiring urgent intervention to raise serum sodium acutely. 3. Inability of the patient to sense or appropriately respond to thirst. 4. Hypovolemic hyponatremia 5. Concomitant use of strong CYP3A(Cytochrome P450, family3, subfamily A) inhibitors 6. Anuric patients 7. Volume depletion patients 8. Hypernatremia patients 9. Women who are pregnant or possibly pregnant and lactation 10. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 11. Patients who are applicable to permanent discontinuation criteria prior to initiation of Samsca® Tablets

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

2023-09-28