NCT06013865 · VA Office of Research and Development
Empagliflozin Treatment in Kidney Transplant Recipients
(SEKTR)
What this study is about
Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time.
View original scientific description
Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors.
Interventions
DRUG
Empagliflozin
SGLT2 Inhibitor
Primary outcome measures
Discontinuation of Empagliflozin
Time frame: about 2 years
The incidence of therapeutic discontinuation of empagliflozin in the kidney transplant recipient from time of initiation.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult (\>18 years of age) male and female recipients (all races and ethnicities)
- Subject must be able to understand and provide consent
- Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant
- For subjects with T2DM or post-transplant diabetes (PTDM), measured kidney function by CKD epi eGFR must be 30mL/min/1.73m2 to 59 mL/min/1.73m2 or CKD epi eGFR 60 mL/min/1.73m2 with urinary albumin:creatinine ratio 30 mg/g (or protein:creatinine 100 mg/g).
- For subjects without T2DM or PTDM: measured kidney function by CKD epi eGFR must be 20mL/min/1.73m2 to 59mL/min/1.73m2 or CKD epi eGFR 60 mL/min/1.73m2 with urinary albumin:creatinine ratio 30 mg/g (or protein:creatinine 100 mg/g).
Exclusion criteria
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol
- History of prior pancreas transplant
- CKD epi eGFR \< 30 mL/min/1.73m2 for those with T2DM or \< 20 mL/min/1.73m2 for those without T2DM or anyone with 5mL/min/1.73m2 fall in eGFR per year
- Uncontrolled type 2 diabetes mellitus with most recent A1C\>12%
- History of \>2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year.
- Use of SGLT2i within 90 days
- Documented allergy to SGLT2i
- History of Type I diabetes mellitus
- History of diabetic ketoacidosis
- Indwelling foley catheter or urinary diversion
- Acute rejection in the prior 3 months
- Acute MACE event within 3 months of the study
- Severe congestive heart failure (NYHA functional class III or higher)
- Active mucocutaneous mycotic infection of the groin or external genitalia.
- History of amputation due to peripheral vascular disease and/or diabetic foot ulcers within prior year
- History of malignancy except non-melanoma skin cancer within 2 years of screening
- Known of active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease)
- HIV infected subjects, including those who are well controlled on anti-retrovirals
- Recent (within 6 months) Positive Hep B PCR or active disease
- Hepatitis C virus antibody positive (HCVAb+) subjects who have failed to demonstrate sustained viral remission for more than 12 weeks (after anti-viral treatment)
- Active pregnancy in a female transplant recipient
- A condition, in the eyes of the investigator, that precludes inclusion into the study.
Where
- Hines, Illinois
- Iowa City, Iowa
- Omaha, Nebraska
- Pittsburgh, Pennsylvania
- Nashville, Tennessee
Collaborators
Iowa City VA Health Care System, VA Pittsburgh Healthcare System, VA Tennessee Valley Health Care System, VA Hines Health Care
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations