Empagliflozin for Kidney Transplant Complications
(CREST-KT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a medication called empagliflozin, which helps lower blood sugar, in kidney transplant patients. The study includes patients with and without type 2 diabetes to see if the medication can improve their health. Empagliflozin works by helping the kidneys remove extra sugar from the blood through urine. This medication has been shown to significantly reduce blood glucose levels and is well tolerated in patients with type 2 diabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be using SGLT2 inhibitors (a type of diabetes medication) or active anticoagulants (blood thinners) other than low-dose aspirin.
Is empagliflozin safe for humans?
How is the drug empagliflozin unique for kidney transplant complications?
Empagliflozin is unique because it is a sodium-glucose cotransporter-2 (SGLT2) inhibitor that not only helps manage blood sugar levels but also offers heart and kidney protection, which is beneficial for patients with chronic kidney disease and cardiovascular issues. This dual role makes it different from other treatments that may not provide these additional protective benefits.12467
What data supports the effectiveness of the drug Empagliflozin for kidney transplant complications?
Empagliflozin has been shown to reduce the progression of chronic kidney disease and lower the risk of cardiovascular issues in patients with type 2 diabetes and kidney disease. This suggests it may help with kidney-related complications, although specific data for kidney transplant complications is not provided.24689
Who Is on the Research Team?
Myles Wolf, MD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for kidney transplant recipients, with or without type 2 diabetes, who are 12-60 months post-transplant. They must be on standard immunosuppression and have a stable kidney function (eGFR ≥30). Excluded are those with recent severe rejection episodes, pregnant/nursing women, uncircumcised men, active heavy anticoagulant users, Type I diabetics, multiple organ transplants or high hemoglobin A1c levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline visit including renal biopsy and 3D echocardiogram
Treatment
Participants receive empagliflozin or placebo with follow-up visits every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dapagliflozin
- Empagliflozin
- Placebo
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor