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SGLT2 Inhibitor

Empagliflozin for Kidney Transplant Recipients (SEKTR Trial)

Phase 4
Recruiting
Led By Roslyn B Mannon, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject must have a diagnosis of Type 2 Diabetes Mellitus or post-transplant diabetes mellitus (PTDM) 2DM or PTDM
Subject must be able to travel to and from VAMC for care and monitoring
Must not have
History of prior pancreas transplant
History of >2 urinary tract infections per year or UTIs requiring admission in the last year, or urosepsis in the last year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up over 2 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tested whether a drug could improve health and quality of life for veterans with kidney disease by reducing the risk of cardiovascular disease. Results showed it had a kidney and heart protective effect, improving patient outcomes.

Who is the study for?
This trial is for adult kidney transplant recipients who have type 2 diabetes or post-transplant diabetes, with stable graft function and moderate kidney impairment. They must be able to consent and travel to the VA Medical Center. Exclusions include recent severe infections, uncontrolled diabetes, prior use of SGLT2 inhibitors, certain heart conditions, and a history of significant complications related to diabetes.
What is being tested?
The study tests Empagliflozin's effects on long-term health outcomes in kidney transplant patients with type 2 diabetes. It aims to see if this medication can protect against heart disease and maintain kidney function without causing harm or interacting negatively with anti-rejection drugs.
What are the potential side effects?
Potential side effects may include increased risk of infections (especially fungal), changes in urination patterns, low blood sugar levels when combined with other diabetic medications, dehydration risks due to its diuretic effect, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Type 2 Diabetes or diabetes after an organ transplant.
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I can travel to and from the VA Medical Center for my care.
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My kidney function is reduced but not severely, and I have protein in my urine.
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I understand the study and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a pancreas transplant in the past.
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I've had more than 2 UTIs this year or was hospitalized for UTI/urosepsis.
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I have a fungal infection in my groin or genital area.
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I had a heart attack or stroke in the last 3 months.
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I do not have any active infections, including TB or fungal infections.
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I am HIV positive and on treatment.
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I have been diagnosed with Type I diabetes.
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I have had diabetic ketoacidosis in the past.
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I have experienced organ rejection within the last 3 months.
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My kidney function is declining rapidly.
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I do not have severe heart failure (not NYHA class III or higher).
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I had an amputation due to poor blood flow or diabetic foot ulcers in the last year.
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My latest A1C level was over 12%, indicating uncontrolled type 2 diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~over 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and over 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Discontinuation of Empagliflozin
Secondary study objectives
Acute Cellular Rejection
Acute Graft Dysfunction
Acute graft dysfunction
+13 more

Side effects data

From 2021 Phase 3 trial • 5988 Patients • NCT03057951
15%
Cardiac failure
7%
Hypertension
7%
Hypotension
7%
Urinary tract infection
6%
Renal impairment
6%
Hyperkalaemia
6%
Fall
5%
Atrial fibrillation
5%
Diabetes mellitus
4%
Hyperuricaemia
4%
Anaemia
3%
Acute kidney injury
3%
Pneumonia
2%
COVID-19
2%
Death
2%
Acute myocardial infarction
2%
Cardiac failure congestive
1%
Cardiac failure chronic
1%
Cellulitis
1%
Syncope
1%
Chronic kidney disease
1%
COVID-19 pneumonia
1%
Ischaemic stroke
1%
Coronary artery disease
1%
Basal cell carcinoma
1%
Chronic obstructive pulmonary disease
1%
Myocardial infarction
1%
Sepsis
1%
Transient ischaemic attack
1%
Angina unstable
1%
Cerebrovascular accident
1%
Angina pectoris
1%
Ventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
10 mg Empagliflozin

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: EmpagliflozinExperimental Treatment1 Intervention
Open Label, Empagliflozin 12.5 mg QD
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750

Find a Location

Who is running the clinical trial?

Nashville VA Medical CenterUNKNOWN
3 Previous Clinical Trials
505 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,461 Total Patients Enrolled
Iowa City VA Health Care SystemFED
3 Previous Clinical Trials
35,405 Total Patients Enrolled
~176 spots leftby Mar 2030
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