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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
Approved for 5 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tacrolimus drug levels

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER
1,177 Previous Clinical Trials
1,573,548 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
~7 spots leftby Nov 2025
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