Sodium-glucose cotransporter-2 inhibitor initiation and the short-term risk of hospitalized acute kidney injury (SGLT2 inhibitors and short-term AKI)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23747
• EU PAS number:
  EUPAS23746
• Study ID:
  23747
• Official title and acronym:
  Sodium-glucose cotransporter-2 inhibitor initiation and the short-term risk of hospitalized acute kidney injury (SGLT2 inhibitors and short-term AKI)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  In response to a series of post-marketing safety reports linking sodium-glucose cotransporter-2 (SGLT2) inhibitors to AKI, the U.S. Food and Drug Administration enhanced renal-related warnings on the package inserts of all SGLT2 inhibitors in June 2016. However, subsequent investigations evaluating data from clinical trials and small-observational cohorts have found no such association. Given the rarity of AKI, these studies were likely under-powered to detect AKI-related safety signals.To further our understanding of the kidney-related risk-benefit profiles of SGLT2 inhibitors in the T2DM population, well-designed pharmacoepidemiologic studies are urgently needed. The proposed project will leverage the Truven Health MarketScan® research database to evaluate the association between SGLT2 inhibitor initiation and the risk of hospitalized AKI among commercially insured beneficiaries from the U.S.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of North Carolina at Chapel Hill

Study timelines

Date when funding contract was signed

Planned: 27/04/2018

Actual: 27/04/2018

Study start date

Planned: 27/04/2018

Actual: 27/04/2018

Data analysis start date

Planned: 27/04/2018

Actual: 27/04/2018

Date of final study report

Planned: 27/04/2019

Sources of funding

Other

More details on funding

Unfunded

Study protocol

Initial protocol

SGLT2 inhibitor AKI protocol (version 1)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable