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Samsca PMS in ADPKD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03406286
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : December 17, 2021
Sponsor:
Information provided by (Responsible Party):
Korea Otsuka Pharmaceutical Co., Ltd.

Study Description
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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. The follow-up period shall basically start at the administration start and last until the end of the survey.

Condition or disease Intervention/treatment
Safety Drug: Tolvaptan

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance(PMS) of Safety and Efficacy of Samsca® Tablets in Korean Patients With ADPKD
Actual Study Start Date : July 19, 2016
Estimated Primary Completion Date : November 2025
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety
Drug Information available for: Tolvaptan

Groups and Cohorts
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Intervention Details:
  • Drug: Tolvaptan
    Other Name: Samsca

Outcome Measures
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Primary Outcome Measures :
  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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03406286


Contacts
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Contact: Hyo-Won Jeong jhw0159@otsuka.co.kr

Locations
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Korea, Republic of
Kim Med Clinic Recruiting
Ulsan, Gyeongsangnam-do, Korea, Republic of
Contact: nephrologist         
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03406286    
Other Study ID Numbers: 156-402-00110
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.:
Post Marketing Surveillance
Additional relevant MeSH terms:
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Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs