Samsca PMS in ADPKD Patients

Recruiting

• Conditions: Safety

• Registration Number: NCT03406286
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-19
• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2018-01-14
• Study First Posted: 2018-01-23
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kim Med Clinic; 🇰🇷 Ulsan, Gyeongsangnam-do, Korea, Republic of