Belzutifan special drug use results survey in radically unresectable or metastatic renal cell carcinoma: a postauthorization safety study (PASS) (MK-6482-045)

Study identification

• EU PAS number:
  EUPAS1000000880
• Study ID:
  1000000880
• Official title and acronym:
  Belzutifan special drug use results survey in radically unresectable or metastatic renal cell carcinoma: a postauthorization safety study (PASS) (MK-6482-045)
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  This study will describe adverse events (AEs) in patients with radically unresectable or metastatic renal cell carcinoma (RCC) who are treated with belzutifan in routine practice. The main objective of this study is to monitor the risk of occurrence of hemorrhages and fractures during the administration of belzutifan in patients with RCC.
• Study status:
  Planned

Research institutions and networks

Institutions

Merck Sharp & Dohme LLC

United States

Study timelines

Date when funding contract was signed

Actual:14/07/2025

Study start date

Planned:30/04/2026

Data analysis start date

Planned:28/03/2031

Date of final study report

Planned:27/05/2032

Sources of funding

Pharmaceutical company and other private sector 

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only