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Immunosuppressant

Envarsus XR for Cognitive Function in Kidney Complication Patients

Phase < 1
Recruiting
Led By Elizabeth Cohen, PharmD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-renal transplant on stable TAC IR for at least 6 months who are converting to TAC XR regardless of indication
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test if a different form of the drug tacrolimus can help improve cognitive function in patients.

Who is the study for?
This trial is for post-renal transplant patients who have been on stable immediate-release Tacrolimus for at least 6 months and are switching to extended-release Envarsus XR. They must be receiving care through the Yale-New Haven Transplantation Center, not live in a nursing home, speak English, and be able to consent. Those with acute infections, critical illness, multiorgan transplants, pregnancy or history of dementia/stroke cannot join.Check my eligibility
What is being tested?
The study aims to see if cognitive function improves when patients switch from immediate-release Tacrolimus (TAC IR) to an extended version called Envarsus XR. Cognitive performance will be measured objectively before and after the conversion.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally tacrolimus can cause tremors, high blood pressure, kidney problems, headaches and changes in mood among other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had a kidney transplant and have been on stable immediate-release Tacrolimus for 6 months, now switching to extended-release.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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
cognitive assessment at baseline
cognitive improvement from baseline
Secondary outcome measures
MoCA cognitive assessment
NIH Toolbox cognitive test

Trial Design

1Treatment groups
Experimental Treatment
Group I: adult kidney transplant recipientsExperimental Treatment1 Intervention
Adult kidney transplant recipients on tacrolimus immediate release for at least six months who are being converted to tacrolimus extended release Envarsus XR® (TAC XR) for any reason by a transplant nephrologist and are willing to participate in cognitive assessment will be offered the opportunity to participate in the study. An assessment is also made at the 3 month point as baseline.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,406 Total Patients Enrolled
Veloxis PharmaceuticalsIndustry Sponsor
41 Previous Clinical Trials
3,111 Total Patients Enrolled
Elizabeth Cohen, PharmDPrincipal InvestigatorYale New Haven Hospital

Media Library

Tacrolimus, Extended Release (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT03410654 — Phase < 1
Kidney Complication Research Study Groups: adult kidney transplant recipients
Kidney Complication Clinical Trial 2023: Tacrolimus, Extended Release Highlights & Side Effects. Trial Name: NCT03410654 — Phase < 1
Tacrolimus, Extended Release (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03410654 — Phase < 1

Frequently Asked Questions

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

What other research has been conducted regarding the extended release of Tacrolimus (Envarsus Xr)?

"Presently, 150 studies pertaining to Tacrolimus, Extended Release (Envarsus Xr) are ongoing. Of these trials 18 have reached Phase 3 and 872 medical centres across the United States are participating in them; most notably within Philadelphia, Pennsylvania."

Answered by AI

How many individuals have been accepted into this research project?

"Affirmative, the clinicaltrial.gov registry confirms that this trial is presently recruiting participants. It was initially listed on October 24th 2018 and last modified on May 24th 2022, with 35 individuals needed to be recruited from a single site."

Answered by AI

Are there any current vacancies for volunteers in this clinical trial?

"As per clinicaltrials.gov, this medical study is currently seeking participants for the trial which was first announced on October 24th 2018 and most recently revised on May 24th 2022."

Answered by AI

What medical conditions may be improved by the administration of Tacrolimus, Extended Release (Envarsus Xr)?

"Tacrolimus Extended Release (Envarsus Xr) is prescribed to patients suffering from atopic dermatitis, liver or kidney transplant rejection."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.
2018. "Assessment of Cognitive Function Before and After Conversion From Immediate Release Tacrolimus to Envarsus XR.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03410654.
~1 spots leftby Jul 2024
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