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Completed

NCT Number: NCT03406286

Samsca PMS in ADPKD Patients

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.

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Key information

Conditions

Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kim Med Clinic

Ulsan, Gyeongsangnam-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Tolvaptan

Drug

Other names: Samsca

Primary outcomes

  1. The incidence rate and the number of Adverse Events (AE) / Adverse Drug Response (ADR)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2018
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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