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Calcineurin Inhibitor

Tacrolimus vs Envarsus for Kidney Transplant Rejection

Phase 1

Recruiting

Led By Arman Faravardeh, MD

Research Sponsored by California Institute of Renal Research

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 2 years

Awards & highlights

Study Summary

This trial will assess if Hispanic ethnicity affects the dose of Envarsus needed for first-time kidney transplant patients. The primary endpoint is tacrolimus drug levels at 24 hours and 3 months after conversion to Envarsus. Secondary outcomes include pill counts, safety, and graft rejection/failure.

Eligible Conditions

Kidney Complication
Kidney Transplant Rejection

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tacrolimus drug levels

Trial Design

2Treatment groups

Experimental Treatment

Group I: TacrolimusExperimental Treatment1 Intervention

Control group - Tacrolimus twice daily in addition to standard of care.

Group II: EnvarsusExperimental Treatment1 Intervention

Study group - Envarsus once daily in addition to standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tacrolimus

FDA approved

Tacrolimus

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER

1,120 Previous Clinical Trials

1,521,357 Total Patients Enrolled

Balboa Institute of TransplantationUNKNOWN

California Institute of Renal ResearchLead Sponsor

3 Previous Clinical Trials

117 Total Patients Enrolled

Media Library

Envarsus (Calcineurin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03438773 — Phase 1

Kidney Transplant Rejection Research Study Groups: Envarsus, Tacrolimus

Kidney Transplant Rejection Clinical Trial 2023: Envarsus Highlights & Side Effects. Trial Name: NCT03438773 — Phase 1

Envarsus (Calcineurin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03438773 — Phase 1

Frequently Asked Questions

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

To what ailments is this medication typically prescribed?

"This treatment is efficacious in treating dermatitis, atopic rejection; liver transplant rejection; and kidney transplant rejection."

Answered by AI

Are more participants being accepted into this research endeavor?

"Indeed, the details posted on clinicaltrials.gov verify that this research trial is presently recruiting participants. This project was initially published on July 11th 2018 and has seen its last modification occur February 7th 2023. A total of 50 people need to be enrolled from 1 medical centre."

Answered by AI

To what degree is this treatment modality deemed safe for individuals?

"This medical trial is still in its early stages, so the safety of this treatment was estimated to be a 1 on our scale. There's limited data available that supports both efficacy and safety at this time."

Answered by AI

Has this therapy been investigated in other research investigations?

"Currently, 125 clinical trials are investigating this potential therapy. Out of those studies 12 have advanced to Phase 3 and the vast majority (779) take place in Philadelphia."

Answered by AI

What is the cap on participants for this experiment?

"Affirmative. The clinicaltrials.gov website reveals that this trial, which was initially made available on July 11th 2018, is currently seeking volunteers. Approximately 50 individuals are required at one medical centre for the study to be successful."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients

2018. "Prospective Pilot Feasibility Study Comparing Envarsus Once-a-day to Tacrolimus Twice-a-day Immunosuppressive Regimen on Drug Bioavailability in Hispanic First Time Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03438773.

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