BridgeMD
New treatment option for Lung Transplant; Complications
Official title Early Use of Long-acting Tacrolimus in Lung Transplant Recipients
ClinicalTrials.gov ID: NCT04469842
What this study is testing
What is Tacrolimus Extended Release Oral Tablet [Envarsus]?
Tacrolimus Extended Release Oral Tablet [Envarsus] is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for lung transplant; complications.
Also referred to as Envarsus XR.
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
- Lung transplantation is a life-saving therapy for patients with advanced lung disease, however, necessitates the use of life-long immunosuppressive therapy for the prevention of acute and chronic rejection. The backbone of immunosuppression is the calcineurin-inhibitor class, with tacrolimus being the preferred drug due to its potency and improved side-effect profile.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Status-post single or bilateral lung transplantation
- Participant is able to give informed consent for participation in the study.
- Male or female age 18 years or above.
- Actively receives care at VUMC and is adherent with medical therapies.
You likely can't join if
- History of prior organ transplantation
- History of tacrolimus use prior to transplantation
- Intolerance of tacrolimus (that precludes use)
- Having DSA pre-transplant (Positive virtual crossmatch)
- Active infection with Hepatitis B or C
- Active infection with Human Immunodeficiency Virus (HIV)
See the full eligibility criteria
- Status-post single or bilateral lung transplantation
- Participant is able to give informed consent for participation in the study.
- Male or female age 18 years or above.
- Actively receives care at VUMC and is adherent with medical therapies.
- History of prior organ transplantation
- History of tacrolimus use prior to transplantation
- Intolerance of tacrolimus (that precludes use)
- Having DSA pre-transplant (Positive virtual crossmatch)
- Active infection with Hepatitis B or C
- Active infection with Human Immunodeficiency Virus (HIV)
- Baseline AST / ALT \> three times upper limit normal
- Primary graft dysfunction grade 3 at 72 hours
- Acute kidney injury during index hospitalization that does not resolve to two times the pre-transplant baseline value.
- Contraindication to PO (per os) intake of medications
- Impaired GI absorption (defined as sublingual administration of IR-tacro)
- History of frequent headaches
- Seizure history
- Cannot provide consent (at least verbally)
- Pregnancy or breast-feeding
- Participation in another treatment clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.