A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease (EMPA-KIDNEY)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49688
• EU PAS number:
  EUPAS46175
• Study ID:
  49688
• Official title and acronym:
  A multicentre international randomized parallel group double-blind placebo-controlled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease (EMPA-KIDNEY)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  China

  Germany

  Italy

  Japan

  Malaysia

  United Kingdom

  United States
• Study description:
  The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 241 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 13/04/2018

Study start date

Actual: 01/02/2019

Data analysis start date

Actual: 09/09/2022

Date of final study report

Planned: 19/04/2023

Actual: 28/10/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Study protocol

Initial protocol

EMPA-KIDNEY_Protocol_v2p0

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ClinicalTrial.gov NCT03594110 (https://clinicaltrials.gov/ct2/show/NCT03594110)