Conversion from IR Tacrolimus to XR Tacrolimus for Heart Transplant

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Loyola University Medical Center, Maywood, ILHeart Transplant+1 MoreConversion from IR Tacrolimus to XR Tacrolimus - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Heart Transplant
  • Chronic Kidney Disease

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: 1 year

1 year
Blood pressure
Cardiac allograft vasculopathy
Heart transplant rejection
LDL Cholesterol
Serum glucose
4 weeks
Estimated Glomerular Filtration Rate (eGFR)
Microalbuminuria
Urinary neutrophil gelatinase-associated lipocalin (NGAL)
Baseline
CYP3A5 expressor category

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Extended Release Tacrolimus
1 of 1

Experimental Treatment

42 Total Participants · 1 Treatment Group

Primary Treatment: Conversion from IR Tacrolimus to XR Tacrolimus · No Placebo Group · Phase 4

Extended Release Tacrolimus
Drug
Experimental Group · 1 Intervention: Conversion from IR Tacrolimus to XR Tacrolimus · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Loyola UniversityLead Sponsor
148 Previous Clinical Trials
30,316 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,108 Total Patients Enrolled
Sanjeev Akkina, MDPrincipal InvestigatorLoyola University
1 Previous Clinical Trials
2 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.