Using empagliflozin to assess safety in dialysis patients with kidney failure
Empagliflozin in ESKD - A Feasibility Study
This study is testing whether the medication empagliflozin is safe for people with kidney failure who are on dialysis.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Mississippi Medical Center Academic / other |
| Locations | 2 sites (Jackson, Mississippi and 1 other locations) |
| Trial ID | NCT05687058 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety of empagliflozin in patients with end-stage kidney disease (ESKD) who are on dialysis. Participants will receive empagliflozin for three months in addition to their standard medical care, with follow-up continuing for one month after treatment. The study seeks to gather data on the drug's effects on general health, as well as its pharmacokinetics and pharmacodynamics in this specific patient population. The goal is to prepare for a larger clinical trial assessing the potential benefits of empagliflozin in dialysis patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with end-stage kidney disease requiring dialysis.
Not a fit: Patients with significant comorbidities such as advanced heart failure or active cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options that improve heart health and overall outcomes for dialysis patients.
How similar studies have performed: While SGLT2 inhibitors have shown promise in other populations, this specific application in dialysis patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. age ≥18 years;
2. diagnosis of end-stage kidney disease requiring dialysis, and
3. ability to provide informed consent.
Exclusion Criteria:
1. systolic blood pressure \<100 mm Hg (pre-dialysis for HD patients)
2. two or more episodes of urinary tract infection within the last 12 months
3. history of urinary retention or urinary tract obstruction
4. liver cirrhosis
5. advanced heart failure requiring heart assist device or inotropic support
6. heart or liver transplant recipient
7. major surgery performed within the last 3 months ("major" per the investigator's assessment)
8. major surgery scheduled within 3 months after screening ("major" per the investigator's assessment)
9. active cancer
10. pregnant or lactating women
11. known allergy or hypersensitivity to any SGLT2 inhibitors
12. history of ketoacidosis during the last 12 months
13. any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).
Where this trial is running
Jackson, Mississippi and 1 other locations
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Recruiting)
- Jackson Medicall Mall Dialysis Clinic — Jackson, Mississippi, United States (Recruiting)
Study contacts
- Principal investigator: Yoshitsugu Obi, MD, PhD — University of Mississippi Medical Center
- Study coordinator: Yoshitsugu Obi, MD, PhD
- Email: yobi@umc.edu
- Phone: 601-984-5670
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.