Status:
RECRUITING
Empagliflozin Treatment in Kidney Transplant Recipients
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Iowa City VA Health Care System
VA Pittsburgh Healthcare System
Conditions:
Kidney Transplant
Chronic Kidney Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief Summary
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 continu...
Detailed Description
Background: 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 outc...
Eligibility Criteria
Inclusion
- 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 \< 45ml/min/1.73m2 or CKD epi eGFR 45 mL/min/1.73m2 to 90ml/min/1.73m2 with urinary albumin:creatinine ratio 200 mg/g (or protein:creatinine 300 mg/g).
- For subjects without T2DM or PTDM: measured kidney function by CKD epi eGFR must be 20mL/min/1.73m2 to \< 45ml/min/1.73m2 or CKD epi eGFR 45 mL/min/1.73m2 to 90ml/min/1.73m2 with urinary albumin:creatinine ratio 200 mg/g (or protein:creatinine 300 mg/g).
Exclusion
- 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.
Key Trial Info
Start Date :
April 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT06013865
Start Date
April 5 2024
End Date
March 31 2030
Last Update
May 4 2025
Active Locations (5)
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1
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
2
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2292
3
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
4
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240