← Back to Search

Calcineurin Inhibitor

Envarsus XR vs Tacrolimus for Kidney Failure

Phase 2 & 3
Recruiting
Led By Roberto Gedaly, MD
Research Sponsored by Roberto Gedaly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female who are of childbearing potential will be asked to use 2 different medically acceptable methods of contraception for the duration of the study and at least 1 year post-infusion
End stage renal disease listed for primary solitary kidney transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of transplant and six months post-transplant
Awards & highlights

Study Summary

This trial will compare Envarsus XR to twice-daily tacrolimus for patients with end stage renal disease who are listed for primary solitary kidney transplant.

Who is the study for?
This trial is for English-speaking adults with end-stage renal disease who are listed for their first kidney transplant. They must be willing to use two forms of contraception if they're women of childbearing potential. People can't join if they've had previous transplants, certain infections or cancers, recent blood transfusions, or are on specific medications like anticoagulants.Check my eligibility
What is being tested?
The study compares Envarsus XR®, a once-daily tacrolimus formulation, with the standard twice-daily tacrolimus in patients awaiting a primary solitary kidney transplant. It's an open-label and randomized trial but doesn't include the actual transplant surgery as part of the study.See study design
What are the potential side effects?
Possible side effects from Envarsus XR® and tacrolimus may include increased risk of infection, high blood pressure, tremors, kidney problems including possible damage to the transplanted organ, diabetes after transplantation and lymphoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am using two forms of birth control during and for a year after the study.
Select...
I am on the waiting list for a kidney transplant due to end stage renal disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of transplant and six months post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of transplant and six months post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. Change in the percentage of donor specific antibodies
Changes in the percentage of blood immunologic markers
Secondary outcome measures
Changes in creatinine clearance
Other outcome measures
Changes in GFR

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Envarsus XRExperimental Treatment1 Intervention
0.07-0.14 mg/kg/day every morning orally
Group II: TacrolimusActive Control1 Intervention
0.1 - 0.2 mg/kg/day in 2 divided doses every 12 hours orally
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Envarsus XR
2017
Completed Phase 4
~230

Find a Location

Who is running the clinical trial?

Roberto GedalyLead Sponsor
1 Previous Clinical Trials
9 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,068 Total Patients Enrolled
9 Trials studying Kidney Failure
1,154 Patients Enrolled for Kidney Failure
Roberto Gedaly, MDPrincipal Investigator - University of Kentucky
University of Kentucky Albert B. Chandler Hospital
University Central De Venezuela (Medical School)
2 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

Envarsus XR (Calcineurin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03321656 — Phase 2 & 3
Kidney Failure Research Study Groups: Tacrolimus, Envarsus XR
Kidney Failure Clinical Trial 2023: Envarsus XR Highlights & Side Effects. Trial Name: NCT03321656 — Phase 2 & 3
Envarsus XR (Calcineurin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03321656 — Phase 2 & 3

Frequently Asked Questions

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

How many people are participating in this clinical trial?

"That is correct. The listing on clinicaltrials.gov shows that the trial administrators are still actively recruiting patients for the study. This particular trial was first posted on March 28th, 2019 and received its most recent edit on March 11th, 2022. There is room for 78 more participants at a single location."

Answered by AI

Are we currently looking for volunteers for this research project?

"That is accurate, the listing on clinicaltrials.gov does show that this research study is currently looking for participants. The trial was first announced on March 28th, 2019 and has since been updated on March 11th, 2022. They are hoping to have 78 people sign up at 1 location."

Answered by AI

What medical conditions does Envarsus XR help to ameliorate?

"Envarsus XR can fight dermatitis, atopic, rejection; transplant, liver, and rejection; transplant, kidney."

Answered by AI

How can I get involved in this clinical research?

"The target recruitment for this trial is 78 patients that currently suffer from end stage renal disease and fall in the age bracket of 18 to 70. Additionally, female participants of childbearing potential must commit to using 2 forms of medically acceptable contraception for the duration of the study, as well as 1 year post-infusion."

Answered by AI

Are there other ongoing studies testing Envarsus XR?

"As of now, there are 153 active studies being conducted on Envarsus XR with 18 in Phase 3. However, most clinical trials for Envarsus XR originate from Philadelphia, Pennsylvania with 875 study sites in total."

Answered by AI

Does this research opportunity have an age limit?

"Following the age guidelines set out by this study's inclusion criteria, patients must be between 18 and 70 years old to participate."

Answered by AI

Who else is applying?

What site did they apply to?
University of Kentucky Transplant Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
Roberto Gedaly 2019. "Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03321656.
~11 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top