Empagliflozin for Kidney Transplant Recipients with Diabetes
Empagliflozin Treatment in Kidney Transplant Recipients
Recruiting
Phase 4Interventional Study
Kidney TransplantChronic Kidney Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
264 (estimated)
Sponsor
VA Office of Research and Development · Federal
Who this trial is looking for
This trial is looking for kidney transplant recipients who have type 2 diabetes or related diabetes issues and are interested in trying a new treatment. Participants need to meet specific health conditions and will be monitored throughout the trial.
Are You a Good Fit for This Trial?
Must not be takingSGLT2 inhibitors
Rules you outType 1 diabetesDiabetic ketoacidosisSevere congestive heart failure
You may be able to join if
I am an adult over 18 years old.
I can understand and provide consent.
I received a kidney transplant at least 3 months ago.
My kidney function is within the required range.
You may not be able to join if
I cannot provide consent or follow the study rules.
I have had a pancreas transplant.
My kidney function is below the required level.
I have uncontrolled diabetes.
I have had more than 2 urinary tract infections in the last year.
I used SGLT2 inhibitors in the last 90 days.
I am currently pregnant.
I have a recent serious heart problem.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adult (\>18 years of age) male and female recipients (all races and ethnicities)
2. Subject must be able to understand and provide consent
3. Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant
4. For subjects with T2DM or post-t…
Inclusion Criteria:
1. Adult (\>18 years of age) male and female recipients (all races and ethnicities)
2. Subject must be able to understand and provide consent
3. Recipient of a primary or secondary kidney transplant at least 3 months or longer since transplant
4. 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).
5. 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:
1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. History of prior pancreas transplant
3. 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
4. Uncontrolled type 2 diabetes mellitus with most recent A1C\>12%
5. History of \>2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year.
6. Use of SGLT2i within 90 days
7. Documented allergy to SGLT2i
8. History of Type I diabetes mellitus
9. History of diabetic ketoacidosis
10. Indwelling foley catheter or urinary diversion
11. Acute rejection in the prior 3 months
12. Acute MACE event within 3 months of the study
13. Severe congestive heart failure (NYHA functional class III or higher)
14. Active mucocutaneous mycotic infection of the groin or external genitalia.
15. History of amputation due to peripheral vascular disease and/or diabetic foot ulcers within prior year
16. History of malignancy except non-melanoma skin cancer within 2 years of screening
17. Known of active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease)
18. HIV infected subjects, including those who are well controlled on anti-retrovirals
19. Recent (within 6 months) Positive Hep B PCR or active disease
20. Hepatitis C virus antibody positive (HCVAb+) subjects who have failed to demonstrate sustained viral remission for more than 12 weeks (after anti-viral treatment)
21. Active pregnancy in a female transplant recipient
22. A condition, in the eyes of the investigator, that precludes inclusion into the study.
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