Empagliflozin Treatment in Kidney Transplant Recipients

Part of paid clinical trials in Hines, Illinois.

Sponsor
VA Office of Research and Development
Study ID
NCT06013865
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 5, 2024
Status verified
Apr 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
264 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Empagliflozin
    Open Label, Empagliflozin 12.5 mg QD

Primary Outcome Measure

Discontinuation of Empagliflozin [ Time Frame: about 2 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Edward Hines Jr. VA Hospital, Hines, ILHinesIllinois60141-3030
Rapahel Lopez-Soler, MD
[email protected]
Iowa City VA Health Care System, Iowa City, IAIowa CityIowa52246-2292
Marion L Sanders, MD
[email protected]
319-338-0581
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NEOmahaNebraska68105-1850
Roslyn B Mannon, MD
[email protected]
205-999-7362
Ramesh K Ramalingam
[email protected]
(402) 995-4873
Roslyn B Mannon, MD (PRINCIPAL_INVESTIGATOR)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburghPennsylvania15240
Mohan Ramkumar, MBBS
[email protected]
412-360-3910
Samantha Gray, MS
[email protected]
4123603788
Tennessee Valley Healthcare System Nashville Campus, Nashville, TNNashvilleTennessee37212-2637
Kelly Birdwell, MD
[email protected]
615-873-6974
Cindy A Mambungu, LPN
[email protected]
6153435828

Find similar trials in Hines, IL

By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Edward Hines Jr. VA Hospital, Hines, IL· Hines, ILIowa City VA Health Care System, Iowa City, IA· Iowa City, IAOmaha VA Nebraska-Western Iowa Health Care System, Omaha, NE· Omaha, NEVA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA· Pittsburgh, PATennessee Valley Healthcare System Nashville Campus, Nashville, TN· Nashville, TN

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