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SGLT2 Inhibitor

Empagliflozin for Kidney Transplant Recipients (SEKTR Trial)

Phase 4

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up over 2 years

Awards & highlights

SEKTR 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.Check my eligibility

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.See study design

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.

SEKTR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Type 2 Diabetes or diabetes after an organ transplant.

Select...

I can travel to and from the VA Medical Center for my care.

Select...

My kidney function is reduced but not severely, and I have protein in my urine.

Select...

I understand the study and can give my consent.

SEKTR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ over 2 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Discontinuation of Empagliflozin

Secondary outcome measures

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

Hypertension

Urinary tract infection

Hypotension

Hyperkalaemia

Fall

Renal impairment

Atrial fibrillation

Diabetes mellitus

Anaemia

Hyperuricaemia

Acute kidney injury

Pneumonia

Acute myocardial infarction

COVID-19

Cardiac failure congestive

Death

Myocardial infarction

Cardiac failure chronic

Angina pectoris

Angina unstable

Ventricular tachycardia

COVID-19 pneumonia

Cellulitis

Sepsis

Chronic kidney disease

Coronary artery disease

Chronic obstructive pulmonary disease

Basal cell carcinoma

Cerebrovascular accident

Ischaemic stroke

Syncope

Transient ischaemic attack

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Empagliflozin

SEKTR 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nashville VA Medical CenterUNKNOWN

2 Previous Clinical Trials

280 Total Patients Enrolled

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,189 Total Patients Enrolled

Iowa City VA Health Care SystemFED

3 Previous Clinical Trials

35,405 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to participate in this trial?

"Sadly, the details located on clinicaltrials.gov reveal that this research is no longer enrolling any participants. It was first posted in January of 2024 and last updated in August 2023; however 484 other studies are still actively seeking individuals to participate at this time."

Answered by AI

How many geographical locations are currently hosting this clinical trial?

"Currently, patients can participate in this study at 4 distinct sites. The cities of Omaha, Pittsburgh and Nashville all have a clinical trial centre for the research project. Furthermore, there are several other locations where one can join the investigation. To reduce travel stressors it is best to select the site nearest you if enrolling as a participant."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Empagliflozin Treatment in Kidney Transplant Recipients

2024. "Empagliflozin Treatment in Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06013865.

All > Kidney Transplant