Who is eligible for clinical trial NCT06013865?

Participants must meet the protocol's inclusion criteria for Kidney Transplant. The stated age range is 19 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06013865 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-16

Empagliflozin Treatment in Kidney Transplant Recipients (NCT06013865)

An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: VA Office of Research and Development

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (23 items).

Location: Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois

Age range: 19 Years

🧪 Interventions in This Study

Empagliflozin (DRUG)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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).

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (5 Sites)

Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois
Iowa City VA Health Care System, Iowa City, IA — Iowa City, Iowa
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha, Nebraska
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh, Pennsylvania
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville, Tennessee

📞 Contact the Study Coordinator

Phone: (205) 999-7362

Email: roslyn.mannon@va.gov

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Kidney Transplant

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study — Pittsburgh, Pennsylvania
CAR-T Cell Therapy for Desensitization in Kidney Transplantation — Boston, Massachusetts
Assessment of Biomarker-Guided CNI Substitution In Kidney Transplantation — Birmingham, Alabama
Social Support Counseling Intervention for Kidney Transplant Candidates — Minneapolis, Minnesota
Phenotype Guided Vasoactive Medication During Kidney Transplantation — Los Angeles, California

Explore by condition: All Kidney Transplant clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗