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Immunosuppressant
Extended Release Tacrolimus for Lung Transplant Complications
Phase < 1
Waitlist Available
Led By Anil J Trindade, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Status-post single or bilateral lung transplantation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
Study Summary
This trial will compare the safety and tolerability of LCP-tacrolimus to IR-tacrolimus in lung transplant recipients.
Who is the study for?
This trial is for adults over 18 who have had a lung transplant, can consent to the study, and are treated at VUMC with good adherence to medical therapies. It's not for those with certain infections (Hepatitis B/C, HIV), high liver enzymes, unresolved kidney injury post-transplant, issues taking oral meds, pregnant or breastfeeding women, severe graft dysfunction post-transplantation, GI absorption problems, prior organ transplants or tacrolimus intolerance.Check my eligibility
What is being tested?
The study tests if early use of Long-acting Tacrolimus (LCP-tacrolimus) after lung transplantation is safe and tolerable compared to immediate-release tacrolimus. The goal is to see if LCP-tacrolimus better preserves kidney function while still preventing rejection of the new lungs.See study design
What are the potential side effects?
Tacrolimus may cause side effects like increased risk of infection and cancer development; tremors; headaches; seizures; high blood pressure; low white blood cell count leading to higher infection risk; and kidney problems that could worsen existing renal conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a lung transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety and Tolerability
Secondary outcome measures
Headache frequency and severity
Incidence of acute cellular rejection
Incidence of de novo donor-specific anti-HLA antibodies
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immunosuppression with Extended-Release TacrolimusExperimental Treatment4 Interventions
LCP-tacrolimus administered daily to target a goal trough level of 10-14 ng/mL x 7 months (with Mycophenolate mofetil and prednisone).
Additional standard immunosuppression with either mycophenolate mofetil (500-1500mg twice daily) OR Azathioprine (up to 2mg/kg daily) AND Prednisone (5-10mg daily) will be administered.
Group II: Immunosuppression with Intermediate Release TacrolimusActive Control4 Interventions
IR-tacrolimus administered twice daily to target a goal trough level of 10-14 ng/mL x 7 months (with Mycophenolate mofetil and prednisone). This is currently the standard of care at Vanderbilt University Medical Center and most other lung transplant centers (ISHLT Registry 2019).
Additional standard immunosuppression with either mycophenolate mofetil (500-1500mg twice daily) OR Azathioprine (up to 2mg/kg daily) AND Prednisone (5-10mg daily) will be administered.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2370
Azathioprine
2002
Completed Phase 4
~2340
Tacrolimus Extended Release Oral Tablet [Envarsus]
2017
Completed Phase 3
~30
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,145 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,098 Total Patients Enrolled
Anil J Trindade, MDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures.You are currently enrolled in another study where you are receiving a treatment.I often have headaches.You cannot take tacrolimus due to a bad reaction in the past.I have had a lung transplant.I do not have an active Hepatitis B or C infection.I am currently infected with HIV.My kidney function hasn't returned to normal after a recent hospital stay.I cannot take medications by mouth.You are pregnant or currently breastfeeding.I am 18 years old or older.My organ transplant failed to work properly within 72 hours.I have issues absorbing medications through my stomach.I am unable to give consent by myself.I have had an organ transplant in the past.I have used tacrolimus before my transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Immunosuppression with Intermediate Release Tacrolimus
- Group 2: Immunosuppression with Extended-Release Tacrolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are actively participating in the clinical trial?
"This particular trial is not presently accepting any more patients; the listing was originally posted on October 1st 2022 and updated for the last time on June 6th of that year. If you are still looking to join a medical study, there are currently 10 clinical trials enrolling people with lung transplant complications as well as 540 studies involving Tacrolimus Extended Release Oral Tablet [Envarsus]."
Answered by AI
Is the recruitment phase for this clinical trial still underway?
"The records on clinicaltrials.gov suggest that this trial, posted October 1st 2022 and most recently updated June 6th 2022, is not currently recruiting patients. However, there are 550 other medical trials actively searching for patients at the moment."
Answered by AI
How is Tacrolimus Extended Release Oral Tablet [Envarsus] used to treat patients?
"Tacrolimus Extended Release Oral Tablet [Envarsus] is a popular medication prescribed to treat dermatitis, atopic and other medical issues such as brain inflammation, varicella-zoster virus acute retinal necrosis, and ulcerative colitis."
Answered by AI
What earlier research has been done on the efficacy of Tacrolimus Extended Release Oral Tablet [Envarsus]?
"Presently, 540 research studies concerning Tacrolimus Extended Release Oral Tablet [Envarsus] are ongoing, with 120 in the final phase. Philadelphia is home to many of these trials; however, 17571 different sites are currently running experiments involving this medication."
Answered by AI
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