Empagliflozin Treatment in Kidney Transplant Recipients
SEKTR
An Exploratory Investigation of the Safety of Empagliflozin in Kidney Transplant Recipients (SEKTR)
2 other identifiers
interventional
264
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2024
Longer than P75 for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2023
CompletedFirst Posted
Study publicly available on registry
August 28, 2023
CompletedStudy Start
First participant enrolled
April 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2030
April 21, 2026
April 1, 2026
6 years
August 22, 2023
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Discontinuation of Empagliflozin
The incidence of therapeutic discontinuation of empagliflozin in the kidney transplant recipient from time of initiation.
about 2 years
Secondary Outcomes (16)
Infection
about 2 years
Hypoglycemia
about 2 years
Major cardiorenal events
about 2 years
Acute Graft Dysfunction
about 2 years
Volume Depletion
about 2 years
- +11 more secondary outcomes
Study Arms (1)
Empagliflozin
OTHEROpen Label, Empagliflozin 12.5 mg QD
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Iowa City VA Health Care Systemcollaborator
- VA Pittsburgh Healthcare Systemcollaborator
- VA Tennessee Valley Health Care Systemcollaborator
- VA Hines Health Carecollaborator
Study Sites (5)
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030, United States
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, 52246-2292, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, 68105-1850, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roslyn B Mannon, MD
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2023
First Posted
August 28, 2023
Study Start
April 5, 2024
Primary Completion (Estimated)
March 31, 2030
Study Completion (Estimated)
March 31, 2030
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share