A regulatory non-interventional study to monitor the safety and efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean patients with Chronic Kidney Disease (CKD)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107340
• EU PAS number:
  EUPAS107293
• Study ID:
  107340
• Official title and acronym:
  A regulatory non-interventional study to monitor the safety and efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean patients with Chronic Kidney Disease (CKD)
• DARWIN EU® study:
  No
• Study countries:
  Korea, Republic of
• Study status:
  Ongoing

Study timelines

Date when funding contract was signed

Planned: 01/03/2024

Actual: 29/03/2024

Study start date

Planned: 29/03/2024

Actual: 29/03/2024

Date of final study report

Planned: 27/02/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim Korea

Study protocol

Initial protocol

[Eng]1245-0323-onis-protocol-final-v2-EUPAS.pdf

Regulatory

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