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New treatment option for Kidney Transplant
Official title Empagliflozin Treatment in Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT06013865
What this study is testing
What is Empagliflozin?
Empagliflozin is an investigational medicine, being studied as a potential treatment for kidney transplant.
Also referred to as jardiance.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join 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 people 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...
- For people 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...
You likely can't join 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
See the full eligibility criteria
- 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 people 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...
- For people 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...
- 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
- History of malignancy except non-melanoma skin cancer within 2 years of screening
- Known of active current viral, fungal, mycobacterial, or other infections (including, but not limited to tuberculosis and atypical mycobacterial disease)
- HIV infected people, including those who are well controlled on anti-retrovirals
- Recent (within 6 months) Positive Hep B PCR or active disease
- Hepatitis C virus antibody positive (HCVAb+) people who have failed to demonstrate sustained viral remission for more than 12 weeks (after anti-viral treatment)
- Active pregnancy in a female transplant recipient
- A condition, in the eyes of the investigator, that precludes inclusion into the study.
The study team makes the final eligibility decision.
Where it's taking place
- Hines, Illinois, United States
- Iowa City, Iowa, United States
- Omaha, Nebraska, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hines, Illinois, United States; Iowa City, Iowa, United States; Omaha, Nebraska, United States; Pittsburgh, Pennsylvania, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.