Samsca PMS in ADPKD Patients (NCT03406286)

Study 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.

Conditions studied

Safety

Keywords

Post Marketing Surveillance

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

At least 600 patients will be enrolled for survey period (10 years). Especially, Liver injury cases of all patients in actual use of Samsca® Tablets to slow the progression of cyst development and renal insufficiency will be focused on monitoring.

Inclusion criteria

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 criteria

Exclusion Criteria:

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

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 2,067 participants (actual)
Patient registry: No

Interventions

DrugTolvaptan
Also known as: Samsca

What researchers measure

Primary outcomes

The incidence rate and the number of Adverse Events (AE) / Adverse Drug Response (ADR)
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).
Time frame: 10 years

Study locations

1 site

Kim Med Clinic
Ulsan, Gyeongsangnam-do, South Korea

Registry details

Key details

Study ID: NCT03406286
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Responsible party: Sponsor
First posted: Jan 23, 2018
Start date: Jul 19, 2016
Primary completion: Dec 2024
Completion: Dec 2024
Last update: Jul 24, 2025

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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Samsca PMS in ADPKD Patients