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Immunosuppressant

Envarsus XR for Kidney Transplant (EnvarsusXR Trial)

Phase 4
Waitlist Available
Led By Rachana Srivastava, MD
Research Sponsored by Meghan Pearl, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months
Awards & highlights

EnvarsusXR Trial Summary

This trial is testing if a once-daily oral tacrolimus formulation is better than the current twice-daily tacrolimus formulation in adolescent organ transplant recipients.

Eligible Conditions
  • Kidney Transplant

EnvarsusXR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 2.5 months, 4.5 months, 5 months, 7 months, 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient Reported Distress
Change in Patient Reported Medication Adherence and Barriers
Change in Patient Reported Transplant Symptoms
+2 more
Secondary outcome measures
Incidence of IgG3 and C1q positive Donor Specific Antibodies
Tacrolimus Dose Exposure
Tacrolimus Trough Coefficient of Variation

EnvarsusXR Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B-Envarsus then TacrolimusExperimental Treatment2 Interventions
Envarsus XR® 14 day run-in followed by 4 months of follow-up and then crossing over to immediate release tacrolimus (twice a day oral formulation) with a 14 day run-in followed by 4 months of follow-up.
Group II: Arm A-Tacrolimus then EnvarsusExperimental Treatment2 Interventions
Immediate release tacrolimus (twice a day oral formulation) 14 day run-in followed by 4 months of follow-up and then crossing over to Envarsus XR® with a 14 day run-in followed by 4 months of follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
FDA approved
Tacrolimus
FDA approved

Find a Location

Who is running the clinical trial?

Meghan Pearl, MDLead Sponsor
University of California, Los AngelesLead Sponsor
1,521 Previous Clinical Trials
10,278,903 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,118 Total Patients Enrolled

Frequently Asked Questions

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

For what type of volunteers is this clinical trial best suited?

"This clinical trial is recruiting 28 eligible participants, aged between 13 and 20, that have undergone a successful kidney transplant. In addition to age constraints, applicants must be currently receiving the same dosage of tacrolimus and mycophenolate mofetil (MMF) or enteric-coated mycophenolic acid (EC-MPA) for at least six months prior with no greater than 0.5mg/dose alterations in the last four months. Lastly, it is imperative to note that all enrolled patients should remain compliant with study protocols throughout its duration."

Answered by AI

Does the inclusion criteria allow for participants over 55 years of age?

"Eligible participants for this medical trial must be at least 13 years old but no older than 20."

Answered by AI

Are there any vacancies available for individuals interested in participating in this research?

"This trial is presently in a inactive state, with the original posting on January 15th 2019 and last edit occurring April 15th of this year. If you are curious about other studies that may be seeking participants, there are currently 85 medical trials for kidney related issues as well as 150 utilizing Envarsus XR medication."

Answered by AI

How many volunteers are participating in this experimental research?

"This clinical trial has closed enrollment. It was first posted on January 15th, 2019 and last edited on April 15th, 2019. In the event you are looking for other medical trials to join, there are presently 85 studies involving kidney-related issues as well as 150 Envarsus XR trials actively recruiting patients."

Answered by AI

What ailments would a doctor typically recommend Envarsus XR for?

"Envarsus XR offers a potential solution for those suffering from dermatitis, atopic conditions, and organ rejection following liver or kidney transplantation."

Answered by AI

What are the known safety profiles of Envarsus XR for patients?

"The approved status of Envarsus XR allows us to confidently rate its safety as a 3 on our scale."

Answered by AI

What past experiments apply to Envarsus XR's therapeutic efficacy?

"At this time, 150 clinical trials are active for Envarsus XR. Of those studies, 18 have reached Phase 3 while the remaining ones remain in earlier stages of research. The majority of these tests take place at sites based out of Nashville but 871 other locations around the world are also running such trials."

Answered by AI
Recent research and studies
~5 spots leftby Mar 2025