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Calcineurin Inhibitor
Envarsus XR for Kidney Transplant Patients (OPERATOR Trial)
Phase 4
Waitlist Available
Led By Anthony Langone, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 4
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial is testing whether a different immunosuppressant drug may improve cognitive function in renal transplant patients.
Who is the study for?
This trial is for English-speaking adults aged 18-70 who've had a kidney transplant between 4 weeks and 10 years ago. They must be on a stable dose of Tacrolimus with specific blood levels, not planning to start interfering medications, and have no severe visual/hearing impairments or medical conditions that could affect participation.
What is being tested?
The study tests if switching from twice-daily Tacrolimus (Prograf) to Envarsus XR improves cognitive function in stable renal transplant patients. It assesses the impact of this medication change on their mental capabilities and quality of life.
What are the potential side effects?
While the trial focuses on cognitive outcomes rather than side effects, changes in immunosuppressive therapy can potentially lead to altered drug absorption rates, which may influence the frequency or severity of typical side effects such as tremors, high blood pressure, kidney function issues, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to month 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in cognitive function-Global on Covid-19 telephone battery
Change in cognitive function-Global on RBANS
Secondary study objectives
Change in cognitive function on Trail making part A
Change in cognitive function on Trail making part B
Change in quality of life
+3 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Change from Prograf to EnvarsusExperimental Treatment1 Intervention
All participants will be switched from Prograf to Envarsus
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
900 Previous Clinical Trials
939,446 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,010 Total Patients Enrolled
Anthony Langone, MD4.611 ReviewsPrincipal Investigator - VUMC
Vanderbilt University Medical Center
5Patient Review
Dr. Langone has been my Dr. since my kidney transplant 8 years ago. He is an excellent Dr. There is not a better Dr. out there.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received an organ transplant, except for a kidney.You have dementia, a condition that affects memory and thinking abilities.You have had surgery to remove a brain tumor or currently have a brain tumor.You have a condition called mental retardation, which affects your intellectual abilities.You have received a kidney transplant between 4 weeks and 10 years ago.You are currently using drugs or alcohol in a harmful way, according to the doctor in charge of the study.You have had a serious injury to your brain.You have been diagnosed with severe mental health conditions like bipolar psychosis or schizophrenia, as determined by the doctors.Your major organs, except for the kidneys, are not functioning properly.
Research Study Groups:
This trial has the following groups:- Group 1: Change from Prograf to Envarsus
Awards:
This trial has 5 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Timeline:
This trial has the following timeline:- 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.
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