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Empagliflozin Treatment in Kidney Transplant Recipients
NCT06013865 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Empagliflozin
Study Locations (5)
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines
Iowa
- Iowa City VA Health Care System, Iowa City, IA — Iowa City
Nebraska
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha
Pennsylvania
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA — Pittsburgh
Tennessee
- Tennessee Valley Healthcare System Nashville Campus, Nashville, TN — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2024-04-05 |
| Est. Completion | 2030-03-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06013865
The ClinicalTrials.gov registry entry for NCT06013865 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 264 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Chronic Kidney Disease appearing as the primary indexed condition, and to 1 intervention — of which Empagliflozin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06013865 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Iowa, Nebraska. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06013865 about?
NCT06013865 is a clinical study titled "Empagliflozin Treatment in Kidney Transplant Recipients". 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 r...
What is the current status of trial NCT06013865?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 264 participants. The study started on 2024-04-05. Estimated completion is 2030-03-31.
What conditions does trial NCT06013865 study?
This clinical trial studies the following conditions: Chronic Kidney Disease, Kidney Transplant. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06013865?
The interventions under investigation include: Empagliflozin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06013865?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06013865 being conducted?
This trial has 5 study locations across Illinois, Iowa, Nebraska, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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