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Immunosuppressant

XR Tacrolimus for Heart Transplant Recipients

Phase 4
Recruiting
Led By Sanjeev Akkina, MD
Research Sponsored by Loyola University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently taking IR Tacrolimus
18-80 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing whether a once-daily tacrolimus pill leads to less kidney damage and better function than the current tacrolimus pill taken multiple times a day.

Who is the study for?
This trial is for heart transplant recipients aged 18-80, within 10 years post-transplant, currently on IR Tacrolimus with stable function and a baseline kidney filtration rate (eGFR) over 30. It excludes those under 18 or over 80, with active cancer, recent rejection episodes, multiple organ transplants or more than a decade since their heart transplant.Check my eligibility
What is being tested?
The study tests the effects of switching from Immediate Release (IR) Tacrolimus to Extended Release (XR) Tacrolimus in heart transplant patients. The goal is to see if XR Tacrolimus causes less kidney tubular injury due to its lower peak levels but similar overall exposure as IR.See study design
What are the potential side effects?
While not specified here, tacrolimus can generally cause side effects like tremors, high blood pressure, kidney problems, diabetes after transplantation and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently on IR Tacrolimus medication.
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I am between 18 and 80 years old.
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I received a heart transplant within the last 10 years and my condition is stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Urinary neutrophil gelatinase-associated lipocalin (NGAL)
Secondary outcome measures
Blood pressure
CYP3A5 expressor category
Cardiac allograft vasculopathy
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Extended Release TacrolimusExperimental Treatment1 Intervention
All participants who consent to the study will be in this group.

Find a Location

Who is running the clinical trial?

Loyola UniversityLead Sponsor
156 Previous Clinical Trials
30,880 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,104 Total Patients Enrolled
Sanjeev Akkina, MDPrincipal InvestigatorLoyola University
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Tacrolimus (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT04917718 — Phase 4
Heart Transplant Research Study Groups: Extended Release Tacrolimus
Heart Transplant Clinical Trial 2023: Tacrolimus Highlights & Side Effects. Trial Name: NCT04917718 — Phase 4
Tacrolimus (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04917718 — Phase 4

Frequently Asked Questions

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

What is the total number of participants recruited for this experiment?

"Affirmative. According to the available data on clinicaltrials.gov, this study is actively seeking participants; it first opened for enrollment on August 16th 2021 and was recently updated April 12th 2022. 42 people are required from a single site."

Answered by AI

What medical conditions are often addressed by transitioning from IR Tacrolimus to XR Tacrolimus?

"Conversion from IR Tacrolimus to XR Tacrolimus is a frequently prescribed treatment for atopic dermatitis. Research has also established that this medication can be an effective remedy against liver and kidney transplant rejection, psoriasis, as well as other conditions."

Answered by AI

Could I potentially participate in this investigation?

"The criteria for enrollment in this clinical trial is quite specific: patients must be afflicted with a form of kidney disease and aged between 18 - 80. The maximum number of participants being sought out amounts to 42 individuals."

Answered by AI

Does this research offer inclusion to individuals below the age of seventy-five?

"To be eligible for this medical research, individuals must be of legal age and under 80 years old. Participants younger than 18 are required to join 88 other trials while those over 65 can sign up for 582 studies."

Answered by AI

Is a shift from immediate-release to extended-release tacrolimus generally secure for patients?

"With the medication already approved, our team has assigned a score of 3 to Conversion from IR Tacrolimus to XR Tacrolimus in terms of safety."

Answered by AI

Are any participants being enrolled in this research protocol at present?

"As indicated by the data on clinicaltrials.gov, this study is currently enlisting volunteers for participation. This trial was initially published on August 16th 2021 and has been revised most recently on April 12th 2022."

Answered by AI

Are there any records of transitioning from immediate release to extended release tacrolimus?

"Currently, 150 clinical trials are in progress to assess the efficacy of Conversion from IR Tacrolimus to XR Tacrolimus. Of those studies, 18 have progressed into phase 3 and 871 locations around the world are running these investigations. Nashville, Tennessee is host to a majority of these medical experiments."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
What site did they apply to?
Loyola University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I had lithium toxicity at age 23 . Toxic level was 4.0 this caused traumatic injury to my kidneys . I’ve been treated for CKD shortly after that and still am today 40 years later. Looking for something that will lengthen my life span.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long is the study ?
PatientReceived no prior treatments
Recent research and studies
~9 spots leftby Dec 2024