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XR Tacrolimus for Heart Transplant Recipients
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am currently on IR Tacrolimus medication.Your kidney function, measured as eGFR, is higher than 30 mL/min/1.73m2.I had a heart transplant over 10 years ago, or I have cancer or rejection issues post-transplant.I am under 18 years old.I am between 18 and 80 years old.I have received transplants for more than one organ.I am over 80 years old.I received a heart transplant within the last 10 years and my condition is stable.
- Group 1: Extended Release Tacrolimus
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
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."
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."
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."
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."
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