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Calcineurin Inhibitor

Standard of care tacrolimus twice-daily for Kidney Transplant Rejection

Phase 3
Waitlist Available
Research Sponsored by Lorenzo Gallon
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 measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant
Awards & highlights

Study Summary

This trial will compare the effects of two different doses of tacrolimus on T and B cells, alloreactive T cells, and renal allograft function.

Eligible Conditions
  • Kidney Transplant Rejection
  • Kidney Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 2 weeks post transplant, 3 months post transplant, 12 months post transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Kidney Transplant Function From 2 Weeks Post Transplant Through 12 Months Post Transplant
Secondary outcome measures
Change in Subpopulations of T Cells From 2 Weeks Post Transplant Through 12 Months Post Transplant
Number of Participants With Acute Rejection at 3 Months and 12 Months Post-Transplant
Number of Participants With Change in Allograft Immunohistopathology Profile
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Standard of care tacrolimus twice-dailyActive Control1 Intervention
Group II: Extended-release tacrolimus once-dailyActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Lorenzo GallonLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled

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
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
Lorenzo Gallon 2017. "Extended Release Tacrolimus vs. Twice-Daily Tacrolimus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03289650.
~4 spots leftby Apr 2025
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