Empagliflozin Treatment in Kidney Transplant Recipients
Recruiting · NCT06013865 · Interventional (participants receive a specific treatment) · Lead sponsor: VA Office of Research and Development
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.
Who can take part
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 it is running
5 locations listed across 5 US states.
- Edward Hines Jr. VA Hospital, Hines, IL - Hines, Illinois, United States
- Iowa City VA Health Care System, Iowa City, IA - Iowa City, Iowa, United States
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE - Omaha, Nebraska, United States
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA - Pittsburgh, Pennsylvania, United States
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN - Nashville, Tennessee, United States