Kidney Failure, ChronicPhase 1/2NCT05687058
Empagliflozin in ESKD - A Feasibility Study
A Phase 1/2 study testing Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing and Empagliflozin 10 mg daily dosing in people with Kidney Failure, Chronic and Heart Failure, run by University of Mississippi Medical Center at 2 sites in United States.
Trial summary
The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Heart Failure
- What is being tested?
- Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing and Empagliflozin 10 mg daily dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2023to 20 Jun 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years;
- diagnosis of end-stage kidney disease requiring dialysis, and
- ability to provide informed consent.
Who cannot join
- systolic blood pressure <100 mm Hg (pre-dialysis for HD patients)
- two or more episodes of urinary tract infection within the last 12 months
- history of urinary retention or urinary tract obstruction
- liver cirrhosis
- advanced heart failure requiring heart assist device or inotropic support
- heart or liver transplant recipient
Show all 13Show fewer
- major surgery performed within the last 3 months ("major" per the investigator's assessment)
- major surgery scheduled within 3 months after screening ("major" per the investigator's assessment)
- active cancer
- pregnant or lactating women
- known allergy or hypersensitivity to any SGLT2 inhibitors
- history of ketoacidosis during the last 12 months
- any other medical condition considered unappropriated by their nephrologists or a study physician (i.e., cachexia, short life expectancy, or uncontrolled personality/phycological disorder).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Mississippi Medical Center
Jackson, Mississippi, 39157
Jackson Medicall Mall Dialysis Clinic
Jackson, Mississippi, 39213
About this study
The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin.
Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.
Read the detailed description
The incidence of end-stage kidney disease (ESKD) in the US ranks among the highest in the world. ESKD is the last phase of chronic kidney disease when the kidneys are functioning below 10-15% of normal capacity, and the patient is on dialysis. According to the US Renal Data System (USRDS), 120,834 individuals started dialysis and nearly 524,000 people were living on dialysis in 2017.1 Although advancement in technology and general medical care has led to a modest decrease in mortality among dialysis patients, their mortality rate remains extremely high at approximately 16.5 per 100 patient-years. The leading cause of death among dialysis patients is cardiovascular disease (CVD), accounting for almost 45% of deaths. Unfortunately, established therapies to prevent incident CVD in the general population, such as renin-angiotensin system inhibitors or statins, have not been shown to be effective in the dialysis population.
Sodium-glucose transporter type 2 (SGLT2) inhibitors are originally approved by FDA for the treatment for type 2 diabetes. SGLT2 is localized to the brush border of the early proximal tubule, and hence, SGLT2inhibitors induce osmotic diuresis and natriuresis but do not activate the systemic renin-angiotensin-aldosterone system.2 Recent clinical trials have consistently shown their potent renal and cardiovascular benefits in both diabetic and non-diabetic patients, which cannot be explained only by their glucose-lowering and diuretic properties. In fact, diuretics have not been shown to reduce cardiovascular mortality and such benefits of SGLT2 inhibitors are clear even among non-diabetic populations.3-5 Their renoprotective effect potentially extends to the dialysis population where residual kidney function (RKF) still plays a major role in solute clearance and volume control and has a strong association with patient outcomes.6 Patients who retain greater RKF can consume a more liberal diet and have better nutritional status, less pill burden, better blood pressure, and less interdialytic fluid gain with less frequent intradialytic hypotension, as well as greater quality of life and better survival.6 The pathophysiology underlying the cardiovascular benefits of SGLT2 inhibitors are yet to be fully elucidated, but a recent in-vitro studies indicate its direct effects on cardiomyocytes. Therefore, the investigators hypothesize that dialysis patients also benefit from SGLT2 inhibitors even if they do not have any RKF.
Efficacy and safety studies with SGLT2 inhibitors did not enroll end-stage kidney disease (ESKD) patients on dialysis. Empagliflozin, canagliflozin, and dapagliflozin can be started if the glomerular filtration rate is more than 20-25 mL/min per 1.73 m2 and can be continued until dialysis initiation or kidney transplant. From a pharmacokinetics standpoint, those SGLT2 inhibitors are extensively metabolized by glucuronidation into inactive metabolites, and are not likely to cause dose-dependent toxicity even in ESKD. Nevertheless, extra caution is necessary for their use in the setting of ESKD because SGLT2 inhibitors are not well dialyzable due to large distribution volumes and high protein binding rates.
Our overall goal is to conduct a non-randomized feasibility clinical trial of empagliflozin in the dialysis population to obtain data that will help plan future larger, sufficiently powered efficacy clinical trials. The investigators plan to enroll a total of 24 dialysis patients (18 patients on hemodialysis and 6 patients on peritoneal dialysis). After one month of the run-in period, participants will take oral empagliflozin for 3 months.
*Hemodialysis is a form of renal replacement therapy that utilizes an external filter (dialyzer) to remove wastes from the bloodstream. Peritoneal dialysis utilizes the peritoneum as a filter to remove wastes.
- Conditions
- Kidney Failure, Chronic, Heart Failure
- Being tested
- Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing, Empagliflozin 10 mg daily dosing
- Keywords
- empagliflozin, end-stage kidney disease, pharmacokinetics, pharmacodynamics, feasibility trial, heart failure, residual kidney function, Sodium-glucose transporter type 2 inhibitor
- Medical subject headings
- Kidney Failure, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 25 mg thrice-weekly post-hemodialysis dosingDrug
Also called Jardiance 25 mg thrice-weekly post-hemodialysis dosing
Participants in Group I will be asked to take empagliflozin 25 mg after each hemodialysis session at home.
Empagliflozin 10 mg daily dosingDrug
Also called Jardiance 10 mg daily dosing
Participants assigned to Group II will be asked to take empagliflozin 10 mg each morning between 8:30 and 9:30 a.m. at home.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing | Experimental | All participants undergoing thrice-weekly hemodialysis (HD) on the Monday-Wednesday-Friday (MWF) schedule will be assigned to the empagliflozin 25 mg thrice-weekly post-hemodialysis dosing arm (Group I). Receives: Drug: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing |
| Empagliflozin 10 mg daily dosing | Experimental | Patients undergoing thrice-weekly hemodialysis (HD) on the Tuesday-Thursday-Saturday (TTS) schedule, patients on twice-weekly HD, or patients on peritoneal dialysis will receive empagliflozin 10 mg daily (Group II). Receives: Drug: Empagliflozin 10 mg daily dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible patients out of screened patients
Measured: During the screening process
Success rate of obtaining consent from those eligible patients
Measured: During the enrollment process
Proportion of missing doses
The investigators will do pill count using medication bottles and calculate the proportion of missing doses from each patient.
Measured: 3 months
Proportion of empagliflozin discontinuation
Proportion of participants who discontinue empagliflozin for any reason
Measured: 3 months
Dropout rate
Proportion of participants who dropped out from the study for any reason
Measured: 3 months
Length of time on continuous glucose monitoring
Continuous glucose monitoring will be done for up to 14 days.
Measured: 3 months
Completion rate of timed urine collection
Measured: 3 months
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 1st blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: Immediately before the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 2nd blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 30 minutes of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 3rd blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 1 hour of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 4th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 1.5 hours of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 5th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 2 hours of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 6th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 3 hours of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 7th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 4 hours of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 8th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 8 hours of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 9th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 12 hours of the first dose
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
The 10th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Measured: At 24 hours of the first dose
Random blood empagliflozin level
Time since the last dose will be recorded.
Measured: At Month 1
Random blood empagliflozin level
Time since the last dose will be recorded.
Measured: At Month 2
Random blood empagliflozin level
Time since the last dose will be recorded.
Measured: At Month 3
Peritoneal dialysis clearance of empagliflozin
Peritoneal dialysis fluid will be collected for 24 hours.
Measured: At Month 3
Secondary outcomes (66)
Number of Participants with Hepatic injury
defined by an elevation of AST and/or ALT >3-fold upper limit of normal (ULN) combined with an elevation of total bilirubin >2-fold ULN measured, and/or marked peak aminotransferase (ALT and/or AST) elevations ≥5-fold ULN
Measured: 3 months
Number of Participants with Ketoacidosis
defined by elevated serum beta hydroxybutyrate ≥3.0 mmol/L
Measured: 3 months
Number of Participants with Lower limb amputation
defined by any non-trauma-related event leading to a lower limb procedure of amputation, auto-amputation or disarticulation
Measured: 3 months
Number of Participants with Symptomatic urinary tract infection
defined by symptoms consistent with urinary tract infection plus pyuria and bacteriuria - urine culture sample has to be taken and sent to central lab for confirmation of the diagnosis
Measured: 3 months
Number of Participants with genital infection
per patient report
Measured: 3 months
Number of Participants with Tinea cruris
per patient report
Measured: 3 months
Number of Participants with Nausea
per patient report
Measured: 3 months
Number of Participants with Vomiting
per patient report
Measured: 3 months
Number of Participants with Skin and soft tissue infection
per patient report
Measured: 3 months
Days on continuous glucose monitoring (CGM)
Per CGM report
Measured: Run in (within one month prior to the study start)
Days on continuous glucose monitoring (CGM)
Per CGM report
Measured: At Month 0
Days on continuous glucose monitoring (CGM)
Per CGM report
Measured: At Month 2
% Time of active CGM
Per CGM report
Measured: Run in (within one month prior to the study start)
% Time of active CGM
Per CGM report
Measured: At Month 0
% Time of active CGM
Per CGM report
Measured: At Month 2
Average glucose
Per CGM report
Measured: Run in (within one month prior to the study start)
Average glucose
Per CGM report
Measured: At Month 0
Average glucose
Per CGM report
Measured: At Month 2
Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days)
Per CGM report
Measured: Run in (within one month prior to the study start)
Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days)
Per CGM report
Measured: At Month 0
Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days)
Per CGM report
Measured: At Month 2
Glucose variability
Per CGM report
Measured: Run in (within one month prior to the study start)
Glucose variability
Per CGM report
Measured: At Month 0
Glucose variability
Per CGM report
Measured: At Month 2
Time in very high range (%)
Percent time for plasma glucose >250 mg/dL
Measured: Run in (within one month prior to the study start)
Time in very high range (%)
Percent time for plasma glucose >250 mg/dL
Measured: At Month 0
Time in very high range (%)
Percent time for plasma glucose >250 mg/dL
Measured: At Month 2
Time in high range (%)
Percent time for plasma glucose >180 to 250 mg/dL
Measured: Run in (within one month prior to the study start)
Time in high range (%)
Percent time for plasma glucose >180 to 250 mg/dL
Measured: At Month 0
Time in high range (%)
Percent time for plasma glucose >180 to 250 mg/dL
Measured: At Month 2
Time in target range (%)
Percent time for plasma glucose >70 to 180 mg/dL
Measured: Run in (within one month prior to the study start)
Time in target range (%)
Percent time for plasma glucose >70 to 180 mg/dL
Measured: At Month 0
Time in target range (%)
Percent time for plasma glucose >70 to 180 mg/dL
Measured: At Month 2
Time in low range (%)
Percent time for plasma glucose >54 to 70 mg/dL
Measured: Run in (within one month prior to the study start)
Time in low range (%)
Percent time for plasma glucose >54 to 70 mg/dL
Measured: At Month 0
Time in low range (%)
Percent time for plasma glucose >54 to 70 mg/dL
Measured: At Month 2
Time in very low range (%)
Percent time for plasma glucose 54 mg/dL or lower
Measured: Run in (within one month prior to the study start)
Time in very low range (%)
Percent time for plasma glucose 54 mg/dL or lower
Measured: At Month 0
Time in very low range (%)
Percent time for plasma glucose 54 mg/dL or lower
Measured: At Month 2
Number of Participants with Hypoglycemia levels 1
Plasma glucose <70 mg/dL for ≥15 minutes
Measured: Run in (within one month prior to the study start)
Number of Participants with Hypoglycemia levels 1
Plasma glucose <70 mg/dL for ≥15 minutes
Measured: At Month 0
Number of Participants with Hypoglycemia levels 1
Plasma glucose <70 mg/dL for ≥15 minutes
Measured: At Month 2
Number of Participants with Hypoglycemia levels 2
Plasma glucose <54 mg/dL for ≥15 minutes
Measured: Run in (within one month prior to the study start)
Number of Participants with Hypoglycemia levels 2
Plasma glucose <54 mg/dL for ≥15 minutes
Measured: At Month 0
Number of Participants with Hypoglycemia levels 2
Plasma glucose <54 mg/dL for ≥15 minutes
Measured: At Month 2
Number of Participants with Prolonged hypoglycemia
Plasma glucose <54 mg/dL for ≥2.0 hours
Measured: Run in (within one month prior to the study start)
Number of Participants with Prolonged hypoglycemia
Plasma glucose <54 mg/dL for ≥2.0 hours
Measured: At Month 0
Number of Participants with Prolonged hypoglycemia
Plasma glucose <54 mg/dL for ≥2.0 hours
Measured: At Month 2
Changes from baseline to Month 3 in left ventricular end-diastolic volume
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in left ventricular end-systolic volume
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in left ventricular mass index
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in left ventricular ejection fraction
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in left ventricular diastolic function
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in longitudinal global strain
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in radial global strain
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in circumferential global strain
To be evaluated by transthoracic echocardiogram (optional)
Measured: 3 months
Changes from baseline to Month 3 in home systolic blood pressure
Measured: 3 months
Changes from baseline to Month 3 in home diastolic blood pressure
Measured: 3 months
Changes from baseline to Month 3 in Kidney Disease Quality of Life (KDQOL)-36 questionnaire
Details are available at the URL below. https://www.rand.org/content/dam/rand/www/external/health/surveys_tools/kdqol/kdqol36.pdf
Measured: 3 months
Changes from baseline to Month 3 in residual kidney function
Renal urea clearance
Measured: 3 months
Changes from baseline to Month 3 in hemoglobin
Measured: 3 months
Changes from baseline to Month 3 in erythropoiesis stimulating drug dose
Measured: 3 months
Hospitalization/Emergency room visit rate for heart failure
Measured: 3 months
Cardiovascular mortality
Measured: 3 months
All-cause mortality
Measured: 3 months
Changes Estimated glomerular filtration rate (GFR) from baseline to Month 3
Estimated by Cystatin C and beta-2 macroglobulin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start1 Nov 2023
- Primary completion4 May 2026
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, non-randomized, two-arm intervention study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yoshitsugu Obi, MD, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687058
- Sponsor's protocol ID
- UMMC-Neph-EMPESKD-01
- Status last verified
- May 2026
- First submitted
- 16 Sep 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be available on request from the corresponding author, Dr. Yoshitsugu Obi, MD. The data are not publicly available due to restrictions e.g. their containing information that could compromise the privacy of research participants.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empagliflozin in ESKD - A Feasibility Study
- ClinicalTrials.gov ID
- NCT05687058
- Acronym / sponsor ID
- UMMC-Neph-EMPESKD-01
- Conditions
- Kidney Failure, Chronic, Heart Failure
- Keywords
- empagliflozin, end-stage kidney disease, pharmacokinetics, pharmacodynamics, feasibility trial, heart failure, residual kidney function, Sodium-glucose transporter type 2 inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to learn about the safety of empagliflozin in dialysis patients as a preparation for a future large clinical trial. Empagliflozin has been approved by the Food and Drug Administration for the treatment of either type 2 diabetes, heart failure, or chronic kidney disease among patients not on dialysis. The use of empagliflozin has not been studied or approved among patients on dialysis for kidney failure because empagliflozin acts on the kidneys. However, recent experimental studies have indicated that empagliflozin may provide direct heart benefits. Some dialysis patients have substantial residual kidney function, which may be protected by empagliflozin.
Participants will be given empagliflozin for three (3) months on top of the standard of care (usual medical care for participants' condition) and will be followed up until one (1) month after the last dose. The investigators will collect information about participants' general health, obtain blood, urine, and imaging studies, check home blood pressure, monitor home blood sugar levels, and ask health-related questions to assess the safety and potential benefits of empagliflozin over four (4) months, including one month before the three (3)-month empagliflozin treatment.
Detailed description
The incidence of end-stage kidney disease (ESKD) in the US ranks among the highest in the world. ESKD is the last phase of chronic kidney disease when the kidneys are functioning below 10-15% of normal capacity, and the patient is on dialysis. According to the US Renal Data System (USRDS), 120,834 individuals started dialysis and nearly 524,000 people were living on dialysis in 2017.1 Although advancement in technology and general medical care has led to a modest decrease in mortality among dialysis patients, their mortality rate remains extremely high at approximately 16.5 per 100 patient-years. The leading cause of death among dialysis patients is cardiovascular disease (CVD), accounting for almost 45% of deaths. Unfortunately, established therapies to prevent incident CVD in the general population, such as renin-angiotensin system inhibitors or statins, have not been shown to be effective in the dialysis population.
Sodium-glucose transporter type 2 (SGLT2) inhibitors are originally approved by FDA for the treatment for type 2 diabetes. SGLT2 is localized to the brush border of the early proximal tubule, and hence, SGLT2inhibitors induce osmotic diuresis and natriuresis but do not activate the systemic renin-angiotensin-aldosterone system.2 Recent clinical trials have consistently shown their potent renal and cardiovascular benefits in both diabetic and non-diabetic patients, which cannot be explained only by their glucose-lowering and diuretic properties. In fact, diuretics have not been shown to reduce cardiovascular mortality and such benefits of SGLT2 inhibitors are clear even among non-diabetic populations.3-5 Their renoprotective effect potentially extends to the dialysis population where residual kidney function (RKF) still plays a major role in solute clearance and volume control and has a strong association with patient outcomes.6 Patients who retain greater RKF can consume a more liberal diet and have better nutritional status, less pill burden, better blood pressure, and less interdialytic fluid gain with less frequent intradialytic hypotension, as well as greater quality of life and better survival.6 The pathophysiology underlying the cardiovascular benefits of SGLT2 inhibitors are yet to be fully elucidated, but a recent in-vitro studies indicate its direct effects on cardiomyocytes. Therefore, the investigators hypothesize that dialysis patients also benefit from SGLT2 inhibitors even if they do not have any RKF.
Efficacy and safety studies with SGLT2 inhibitors did not enroll end-stage kidney disease (ESKD) patients on dialysis. Empagliflozin, canagliflozin, and dapagliflozin can be started if the glomerular filtration rate is more than 20-25 mL/min per 1.73 m2 and can be continued until dialysis initiation or kidney transplant. From a pharmacokinetics standpoint, those SGLT2 inhibitors are extensively metabolized by glucuronidation into inactive metabolites, and are not likely to cause dose-dependent toxicity even in ESKD. Nevertheless, extra caution is necessary for their use in the setting of ESKD because SGLT2 inhibitors are not well dialyzable due to large distribution volumes and high protein binding rates.
Our overall goal is to conduct a non-randomized feasibility clinical trial of empagliflozin in the dialysis population to obtain data that will help plan future larger, sufficiently powered efficacy clinical trials. The investigators plan to enroll a total of 24 dialysis patients (18 patients on hemodialysis and 6 patients on peritoneal dialysis). After one month of the run-in period, participants will take oral empagliflozin for 3 months.
*Hemodialysis is a form of renal replacement therapy that utilizes an external filter (dialyzer) to remove wastes from the bloodstream. Peritoneal dialysis utilizes the peritoneum as a filter to remove wastes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A single-center, non-randomized, two-arm intervention study
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing | Experimental | Drug: Empagliflozin 25 mg thrice-weekly post-hemodialysis dosingAll participants undergoing thrice-weekly hemodialysis (HD) on the Monday-Wednesday-Friday (MWF) schedule will be assigned to the empagliflozin 25 mg thrice-weekly post-hemodialysis dosing arm (Group I). |
| Empagliflozin 10 mg daily dosing | Experimental | Drug: Empagliflozin 10 mg daily dosingPatients undergoing thrice-weekly hemodialysis (HD) on the Tuesday-Thursday-Saturday (TTS) schedule, patients on twice-weekly HD, or patients on peritoneal dialysis will receive empagliflozin 10 mg daily (Group II). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years;
- diagnosis of end-stage kidney disease requiring dialysis, and
- ability to provide informed consent.
Key exclusion criteria (13 listed)
- systolic blood pressure <100 mm Hg (pre-dialysis for HD patients)
- two or more episodes of urinary tract infection within the last 12 months
- history of urinary retention or urinary tract obstruction
- liver cirrhosis
- advanced heart failure requiring heart assist device or inotropic support
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 25 mg thrice-weekly post-hemodialysis dosingAlso: Jardiance 25 mg thrice-weekly post-hemodialysis dosingParticipants in Group I will be asked to take empagliflozin 25 mg after each hemodialysis session at home. | Drug | Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing |
| Empagliflozin 10 mg daily dosingAlso: Jardiance 10 mg daily dosingParticipants assigned to Group II will be asked to take empagliflozin 10 mg each morning between 8:30 and 9:30 a.m. at home. | Drug | Empagliflozin 10 mg daily dosing |
Primary outcome
Proportion of eligible patients out of screened patients
Time frame: During the screening process
Success rate of obtaining consent from those eligible patients
Time frame: During the enrollment process
Proportion of missing doses
Time frame: 3 months
The investigators will do pill count using medication bottles and calculate the proportion of missing doses from each patient.
Proportion of empagliflozin discontinuation
Time frame: 3 months
Proportion of participants who discontinue empagliflozin for any reason
Dropout rate
Time frame: 3 months
Proportion of participants who dropped out from the study for any reason
Length of time on continuous glucose monitoring
Time frame: 3 months
Continuous glucose monitoring will be done for up to 14 days.
Completion rate of timed urine collection
Time frame: 3 months
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: Immediately before the first dose
The 1st blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 30 minutes of the first dose
The 2nd blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 1 hour of the first dose
The 3rd blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 1.5 hours of the first dose
The 4th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 2 hours of the first dose
The 5th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 3 hours of the first dose
The 6th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 4 hours of the first dose
The 7th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 8 hours of the first dose
The 8th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 12 hours of the first dose
The 9th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Blood empagliflozin concentrations after the first dose among patients on peritoneal dialysis
Time frame: At 24 hours of the first dose
The 10th blood draw for the pharmacokinetic study among patients on peritoneal dialysis
Random blood empagliflozin level
Time frame: At Month 1
Time since the last dose will be recorded.
Random blood empagliflozin level
Time frame: At Month 2
Time since the last dose will be recorded.
Random blood empagliflozin level
Time frame: At Month 3
Time since the last dose will be recorded.
Peritoneal dialysis clearance of empagliflozin
Time frame: At Month 3
Peritoneal dialysis fluid will be collected for 24 hours.
66 secondary outcomes
Number of Participants with Hepatic injury
Time frame: 3 months
Number of Participants with Ketoacidosis
Time frame: 3 months
Number of Participants with Lower limb amputation
Time frame: 3 months
Number of Participants with Symptomatic urinary tract infection
Time frame: 3 months
Number of Participants with genital infection
Time frame: 3 months
Number of Participants with Tinea cruris
Time frame: 3 months
Number of Participants with Nausea
Time frame: 3 months
Number of Participants with Vomiting
Time frame: 3 months
Number of Participants with Skin and soft tissue infection
Time frame: 3 months
Days on continuous glucose monitoring (CGM)
Time frame: Run in (within one month prior to the study start)
Days on continuous glucose monitoring (CGM)
Time frame: At Month 0
Days on continuous glucose monitoring (CGM)
Time frame: At Month 2
% Time of active CGM
Time frame: Run in (within one month prior to the study start)
% Time of active CGM
Time frame: At Month 0
% Time of active CGM
Time frame: At Month 2
Average glucose
Time frame: Run in (within one month prior to the study start)
Average glucose
Time frame: At Month 0
Average glucose
Time frame: At Month 2
Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days)
Time frame: Run in (within one month prior to the study start)
Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days)
Time frame: At Month 0
Glucose management indicator (estimated A1C level based on the average glucose level from CGM readings for 14 or more days)
Time frame: At Month 2
Glucose variability
Time frame: Run in (within one month prior to the study start)
Glucose variability
Time frame: At Month 0
Glucose variability
Time frame: At Month 2
Time in very high range (%)
Time frame: Run in (within one month prior to the study start)
Time in very high range (%)
Time frame: At Month 0
Time in very high range (%)
Time frame: At Month 2
Time in high range (%)
Time frame: Run in (within one month prior to the study start)
Time in high range (%)
Time frame: At Month 0
Time in high range (%)
Time frame: At Month 2
Time in target range (%)
Time frame: Run in (within one month prior to the study start)
Time in target range (%)
Time frame: At Month 0
Time in target range (%)
Time frame: At Month 2
Time in low range (%)
Time frame: Run in (within one month prior to the study start)
Time in low range (%)
Time frame: At Month 0
Time in low range (%)
Time frame: At Month 2
Time in very low range (%)
Time frame: Run in (within one month prior to the study start)
Time in very low range (%)
Time frame: At Month 0
Time in very low range (%)
Time frame: At Month 2
Number of Participants with Hypoglycemia levels 1
Time frame: Run in (within one month prior to the study start)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be available on request from the corresponding author, Dr. Yoshitsugu Obi, MD. The data are not publicly available due to restrictions e.g. their containing information that could compromise the privacy of research participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshitsugu Obi, MD, PhD principal investigator
University of Mississippi Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Empagliflozin 25 mg thrice-weekly post-hemodialysis dosing and Empagliflozin 10 mg daily dosing in people with Kidney Failure, Chronic and Heart Failure, run by University of Mississippi Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of eligible patients out of screened patients (time frame: During the screening process). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.