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Envarsus XR for Kidney Transplant Patients (OPERATOR Trial)
OPERATOR Trial Summary
This trial is testing whether a different immunosuppressant drug may improve cognitive function in renal transplant patients.
OPERATOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.OPERATOR Trial Design
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- 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.
- Group 1: Change from Prograf to Envarsus
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
- 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 purpose of this clinical investigation?
"The main measure of success in this trial is the alteration to cognitive ability as defined by Global RBANS scores. Secondary objectives include change in CGI-I, TMT A performance time, and PIRS-20 sleep quality scores. All results are reported using a Likert scale ranging from 1 (very much improved) to 7 (very much worse)."
Could you enumerate the research conducted on transitioning from Prograf to Envarsus XR?
"At the moment, 150 studies are underway which evaluate the Change from Prograf to Envarsus XR protocol. Out of these trials, 18 are in their final Phase 3 stage. Nashville is a major hub for this research as 871 sites have been established here; however, there may be more locations conducting similar clinical tests across the United States."
How many participants are currently engaged in this trial?
"Affirmative, the information held on clinicaltrials.gov demonstrates that this research is presently recruiting participants. This medical trial was initially posted on June 22nd 2021 and has since gone through multiple revisions; as of August 23rd 2022 there are 60 slots open at a single location."
What indications are typically addressed with the transition from Prograf to Envarsus XR?
"Envarsus XR is a common intervention for treating atopic dermatitis but can also be effective in cases of liver and kidney transplant rejection as well as psoriasis."
Is this experiment accommodating people beyond the age of seventy-five?
"This trial requires all participants to be between the ages 18 and 70. 55 studies are available for individuals younger than 18, whereas 191 studies pertain to those who exceed the age of 65."
Are there remaining vacancies in this clinical trial?
"As revealed on clinicaltrials.gov, this medical research is presently searching for participants. The study was initially posted on June 22nd 2021 and recently updated on August 23rd 2022."
Is the transition from Prograf to Envarsus XR compliant with current FDA legislation?
"This switch from Prograf to Envarsus XR was given a 3 rating on our scale, indicating it is approved for use due the Phase 4 nature of this trial."
For what type of individual is this research best suited?
"To be eligible for this medical trial, potential patients must have had a kidney transplant and their age should fall between 18 to 70 years old. Currently, the team is attempting to recruit approximately 60 individuals."
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