Effects of Empagliflozin on kidney health in survivors of severe acute kidney injury
The Effects of Empagliflozin on Renal Outcomes in Post Severe Acute Kidney Injury Survivors
This study is testing if the diabetes medication Empagliflozin can help improve kidney health in people who have survived severe acute kidney injury.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chulalongkorn University Academic / other |
| Locations | 1 site (Nonthaburi, Mueang Nonthaburi District) |
| Trial ID | NCT05360615 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of Empagliflozin, a medication typically used for diabetes, on renal outcomes in individuals who have survived severe acute kidney injury (AKI) stages 2-3. Participants will be randomly assigned to receive either Empagliflozin or a placebo, and their kidney function will be assessed over time using the MAKE365 endpoint. The goal is to determine if Empagliflozin can improve kidney health in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have survived severe acute kidney injury stages 2-3 and have a creatinine clearance greater than 20.
Not a fit: Patients who are pregnant, have undergone kidney transplantation, have previously used SGLT2 inhibitors, or have a history of ketoacidosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney health and outcomes for survivors of severe acute kidney injury.
How similar studies have performed: While the specific application of Empagliflozin in post-AKI patients is novel, similar studies with SGLT2 inhibitors have shown promise in improving renal outcomes in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * post AKI stage 2-3 * CrCl \> 20 Exclusion Criteria: * pregnancy * post kidney transplant * previous use of SGLT2 Inhibitors * history of ketoacidosis
Where this trial is running
Nonthaburi, Mueang Nonthaburi District
- Central Chest Institute of Thailand — Nonthaburi, Mueang Nonthaburi District, Thailand (Recruiting)
Study contacts
- Principal investigator: Nattachai Srisawat — Chulalongkorn University
- Study coordinator: Sasipha Tachaboon
- Email: sasipha_tac@hotmail.com
- Phone: 022564000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.