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Calcineurin Inhibitor

Study Group for Kidney Transplant Infection

Phase 2
Waitlist Available
Led By Graham C Towns, MD
Research Sponsored by University of Alabama at Birmingham
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 at 300 days
Awards & highlights

Study Summary

This study is evaluating whether Envarsus is as effective as Tacrolimus-IR in preventing BK virus infection.

Eligible Conditions
  • Kidney Transplant Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 300 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 300 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the Safety of Envarsus Treatment as Assessed by CTCAE v4.0.
Number of Participants With Viruria >500 Copies
Participants Will Experience Less BK Infection Episodes Based on Nephropathy Results.
+2 more
Secondary outcome measures
Evaluate the Effect of Envarsus Conversion as Evidenced by a 15% Decrease in Estimated Glomerular Filtration Rate (GFR) and Proteinuria.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment1 Intervention
Post transplant patients (kidney transplant alone) with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, and negative BK screening at month 1, whom have a concentration/dose of < 1 and a steady state therapeutic level will be eligible. Patients will be converted to envarsus at 20% reduction in dose.
Group II: Control GroupActive Control1 Intervention
Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Study Group
2020
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,579 Previous Clinical Trials
2,275,870 Total Patients Enrolled
Graham C Towns, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection
Graham C. Towns 2019. "Conversion to Envarsus Post Kidney Transplant Protects Against BK Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03762473.
~15 spots leftby Apr 2025
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