NCT06013865 Empagliflozin Treatment in Kidney Transplant Recipients
| NCT ID | NCT06013865 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | VA Office of Research and Development |
| Condition | Kidney Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 264 participants |
| Start Date | 2024-04-05 |
| Primary Completion | 2030-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 264 participants in total. It began in 2024-04-05 with a primary completion date of 2030-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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-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.
Contact & Investigator
Roslyn B Mannon, MD
PRINCIPAL INVESTIGATOR
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Frequently Asked Questions
Who can join the NCT06013865 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Kidney Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06013865 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06013865 currently recruiting?
Yes, NCT06013865 is actively recruiting participants. Contact the research team at roslyn.mannon@va.gov for enrollment information.
Where is the NCT06013865 trial being conducted?
This trial is being conducted at Hines, United States, Iowa City, United States, Omaha, United States, Pittsburgh, United States and 1 additional location.
Who is sponsoring the NCT06013865 clinical trial?
NCT06013865 is sponsored by VA Office of Research and Development. The principal investigator is Roslyn B Mannon, MD at Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE. The trial plans to enroll 264 participants.
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