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Calcineurin Inhibitor
Envarsus + IR Tacrolimus for Neurological Side Effects in Elderly Patients
Phase 4
Waitlist Available
Led By Ling-Xin Chen, MD
Research Sponsored by University of California, Davis
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 6 weeks after randomization and baseline testing
Awards & highlights
Study Summary
This trial is testing if a different tacrolimus medication will help elderly patients experience less neurocognitive toxicities.
Eligible Conditions
- Neurotoxicity
- Kidney Complication
- Therapeutic Agent Toxicity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after randomization and baseline testing
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after randomization and baseline testing
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in neurocognitive side effects
Secondary outcome measures
Change in self-reported side effects
Kidney graft survival
Patient survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EnvarsusExperimental Treatment1 Intervention
Patients will be converted to Envarsus formulation of tacrolimus
Group II: Immediate Release TacrolimusActive Control1 Intervention
Patients will receive immediate release tacrolimus
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Envarsus
2020
Completed Phase 4
~130
Find a Location
Who is running the clinical trial?
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,927 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,082 Total Patients Enrolled
Ling-Xin Chen, MDPrincipal InvestigatorUC Davis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a pancreas transplant at the same time as a kidney transplant.You were previously rejected from participating in this study.You had a stroke or mini-stroke after a previous organ transplant and before joining the study.You are unable to see.You are currently taking a specific type of medication called an mTOR inhibitor for ongoing treatment.You have not been taking your medication as prescribed, as shown by low levels of the drug in your body.You have had a kidney transplant.Your new kidney is working well without needing dialysis within 4 weeks after the transplant.Your body mass index (BMI) is less than 35 when you have the transplant.You need to reach a certain level of tacrolimus in your body within 4 weeks after the transplant.You are 60 years old or older at the time of the transplant.You are currently using tacrolimus as a long-term treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Immediate Release Tacrolimus
- Group 2: Envarsus
Awards:
This trial has 3 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the evidence base for Envarsus?
"There are 153 separate ongoing studies investigating Envarsus with 18 of them being in Phase 3. The majority of these research projects are based out of Philadelphia, but there are 875 total clinical trial sites for Envarsus."
Answered by AI
How many people are being included in this research project?
"That is correct, the online data reflects that this study is actively looking for volunteers. The 60 participants will come from a single location, and the trial was initially posted on April 1st, 2018."
Answered by AI
What are the main conditions that Envarsus has been proven to improve?
"Dermatitis and other conditions like psoriasis, rejection after a liver transplant, and rejection after a kidney transplant can often be treated effectively with Envarsus."
Answered by AI
Are new patients able to join this trial at this time?
"Yes, this study is still looking for patients. According to the clinicaltrials.gov website, the trial was originally posted on April 1st 2018 and updated most recently on January 25th 2022."
Answered by AI
What are the government regulations on Envarsus?
"Envarsus is a safe medication, as it has been approved by the FDA."
Answered by AI
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