Samsca PMS in ADPKD Patients

NCT03406286 | Completed

• 1 other identifier: 156-402-00110
• Study Type: observational
• Target: 2,067
• Locations: 1 country
• Sites: 1

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.

Conditions

Safety

Keywords

Post Marketing Surveillance

Outcome Measures

Primary Outcomes (1)

• 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).

  10 years

Interventions

Tolvaptan DRUG

Also known as: Samsca

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Kim Med Clinic

Ulsan, Gyeongsangnam-do, South Korea

Location

MeSH Terms

Interventions

Tolvaptan

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 23, 2018
• Study Start: July 19, 2016
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

KR (1)