Samsca PMS in ADPKD Patients

September 26, 2023 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
    • Gyeongsangnam-do
      • Ulsan, Gyeongsangnam-do, Korea, Republic of
        • Recruiting
        • Kim Med Clinic
        • Contact:
          • nephrologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of liver injury event
Time Frame: 10 years
  • the incidence rate of more than 3 times the upper limit of normal ALT(alanine aminotransaminase) or AST(aspartate aminotransferase) will be presented.
  • the incidence rate of more than 3 times the upper limit of normal ALT or AST and more than 2 times the upper limit of normal total bilirubin will be presented.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2016

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 14, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-402-00110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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