Post-Marketing Surveillance of Samsca in ADPKD Patients

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

This study is testing how safe and effective Samsca® tablets are for people with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Ulsan, Gyeongsangnam-do)
• Trial ID: NCT03406286 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the safety and effectiveness of Samsca® tablets in patients with autosomal dominant polycystic kidney disease (ADPKD) who are experiencing rapid disease progression. It is a post-marketing surveillance initiative that follows Korean regulations and aims to gather real-world data on the drug's use in clinical settings. The study involves a single-arm approach where all eligible patients will be monitored for their response to the treatment over time.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic kidney disease stages 1 to 4 and evidence of rapidly progressing disease.

Not a fit: Patients with hypersensitivity to tolvaptan or those requiring urgent interventions for serum sodium levels may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of Samsca in slowing kidney disease progression.

How similar studies have performed: While this study is focused on post-marketing surveillance, similar studies have shown that monitoring real-world drug use can yield important safety and efficacy data.

Eligibility 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

Where this trial is running

Ulsan, Gyeongsangnam-do

• Kim Med Clinic — Ulsan, Gyeongsangnam-do, Korea, Republic of (RECRUITING)

Study contacts

• Study coordinator: MunJu Cho

Conditions: Safety, Post Marketing Surveillance