Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients with Chronic Kidney Disease in Japan

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000279
• EU PAS number:
  EUPAS1000000279
• Study ID:
  1000000279
• Official title and acronym:
  Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients with Chronic Kidney Disease in Japan
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study status:
  Planned

Study timelines

Date when funding contract was signed

Planned: 15/08/2024

Study start date

Planned: 01/09/2024

Date of final study report

Planned: 30/04/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Nippon Boehringer Ingelheim Co., Ltd.

Study protocol

Initial protocol

observational and non-interventional study protocol 1245-0340_V1.0_redacted.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