Samsca PMS in ADPKD Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03406286

Enrollment

2067

Registered

2018-01-23

Start date

2016-07-19

Completion date

2024-12-31

Last updated

2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety

Keywords

Post Marketing Surveillance

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 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.

Interventions

DRUGTolvaptan

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The incidence rate and the number of Adverse Events (AE) / Adverse Drug Response (ADR)	10 years	All adverse events (AEs) observed during/after the administration will be analyzed as safety assessment. The number of patients and the number of AE, ADR, Serious AE·ADR, Unexpected AE·ADR will be calculated (frequency and percentage).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026