Samsca PMS in ADPKD Patients

Safety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03406286
• Other study ID #: 156-402-00110
• Status: Recruiting
• Start date: July 19, 2016
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: MunJu Cho
• Email: chomunju[@]otsuka.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Safety

Intervention

Drug:
• Tolvaptan

Locations

Country	Name	City	State
Korea, Republic of	Kim Med Clinic	Ulsan	Gyeongsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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