Status:
COMPLETED
Samsca PMS in ADPKD Patients
Lead Sponsor:
Korea Otsuka Pharmaceutical Co., Ltd.
Conditions:
Safety
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 18 years and older patients with CKD(chronic kidney disease) stage 1 to 4 at initiation of treatment with evidence of rapidly progressing disease.
- Patients who need to be prescribed by Investigators who got registered in Risk Management Plan.
- Patients who have agreed and signed on conditions specified in Risk Management Plan.
Exclusion
- Patients with known or suspected hypersensitivity to tolvaptan or chemically related structures such as benzazepines or to any ingredient of the drug
- Patients requiring urgent intervention to raise serum sodium acutely.
- Inability of the patient to sense or appropriately respond to thirst.
- Hypovolemic hyponatremia
- Concomitant use of strong CYP3A(Cytochrome P450, family3, subfamily A) inhibitors
- Anuric patients
- Volume depletion patients
- Hypernatremia patients
- Women who are pregnant or possibly pregnant and lactation
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients who are applicable to permanent discontinuation criteria prior to initiation of Samsca® Tablets
Key Trial Info
Start Date :
July 19 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
2067 Patients enrolled
Trial Details
Trial ID
NCT03406286
Start Date
July 19 2016
End Date
December 1 2024
Last Update
July 24 2025
Active Locations (1)
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1
Kim Med Clinic
Ulsan, Gyeongsangnam-do, South Korea