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The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors

Sponsor
Chulalongkorn University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05360615
Collaborator
(none)
147
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
6.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effects of Empagliflozin compared with placebo in post severe acute kidney injury survivors, evaluated by MAKE365.

Condition or Disease Intervention/Treatment Phase
  • Drug: Empagliflozin 10 MG
  • Drug: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
147 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Empagliflozin

Drug: Empagliflozin 10 MG
SGLT2 inhibitors
Placebo Comparator: Placebo

Drug: Placebo
Placebo

Outcome Measures

Primary Outcome Measures

  1. MAKE365 [1 year]

    Major adverse kidney events (number of participants with death, renal replacement therapy, New CKD, CKD progression)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • post AKI stage 2-3

  • CrCl > 20

Exclusion Criteria:

  • pregnancy

  • post kidney transplant

  • previous use of SGLT2 Inhibitors

  • history of ketoacidosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 Central Chest Institute of Thailand Thailand Nonthaburi Thailand 11000

Sponsors and Collaborators

  • Chulalongkorn University

Investigators

  • Principal Investigator: Nattachai Srisawat, Chulalongkorn University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nattachai Srisawat ,M.D., Assistant Professor.Nattachai Srisawat, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT05360615
Other Study ID Numbers:
  • IRB.211/65
First Posted:
May 4, 2022
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Nattachai Srisawat ,M.D., Assistant Professor.Nattachai Srisawat, Chulalongkorn University
Empagliflozin
AKI
Additional relevant MeSH terms:
Acute Kidney Injury
Empagliflozin

Study Results

No Results Posted as of Jun 22, 2022