← Back to Search

Immunosuppressant

Tacrolimus for Kidney Transplant (TAC3A5 Trial)

Phase 4
Waitlist Available
Led By Alexander Toledo, MD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All new kidney transplant recipients aged 18 to 65 years who are admitted at UNC-CH and provided informed consent will be included in this study.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

TAC3A5 Trial Summary

This trial is investigating the correlation between a patient's CYP3A5 genotype and tacrolimus trough levels (the concentration of the drug in the blood). The primary endpoint is to see if target levels are reached on Days 3 and 7 after kidney transplantation.

TAC3A5 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TAC3A5 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 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
Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation
Kidney
Secondary outcome measures
Mean Number of Dose Adjustments and/or Drug Alterations
Number of Adverse Outcomes
Number of Events of Biopsy Proven Acute Rejection (BPAR)
+2 more
Other outcome measures
Direct and Indirect Costs

Side effects data

From 2022 Phase 4 trial • 97 Patients • NCT03020589
98%
Anemia
83%
Hypomagnesemia
75%
Leukopenia
70%
Hyperkalemia
57%
Abnormal renal function
50%
Hypophosphatemia
50%
Increase creatinine
45%
Hyperglycemia
33%
Delayed Graft Function Requiring Dialysis
30%
Diarrhea
30%
Nausea
28%
Headache
28%
Hypertension
25%
Tremor
25%
Infection
23%
Constipation
23%
Edema
20%
Vomiting
18%
Hyperlipidemia
18%
Hypokalemia
10%
Biopsy Proven Acute Rejection
8%
Neurotoxicity
3%
Graft loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
CYP3A5 Based Tacrolimus Dosing
Control

TAC3A5 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CYP3A5 based tacrolimus dosingExperimental Treatment1 Intervention
Subjects in this treatment arm will receive initial tacrolimus based on their genotype i.e., CYP3A5*1/*1 and CYP3A5*1/*3 (Expressers) will receive the initial tacrolimus dose of 0.2 mg/kg/day, with maximum of 20 mg/day in 2 divided doses. For CYP3A5*3/*3 (Non-Expressers), the subjects will receive initial tacrolimus dose of 0.1 mg/kg/day in 2 divided doses.
Group II: ControlActive Control1 Intervention
Subjects in the prospective control group will receive standard tacrolimus dosing as recommended per package insert and will not be dosed based on their genotype. Similarly, subjects that underwent renal transplant after 2010 and received standard tacrolimus dosing (per package insert) will serve as historical controls.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tacrolimus
2011
Completed Phase 4
~4740

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,945 Total Patients Enrolled
Alexander Toledo, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

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
Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
2017. "Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03020589.
~12 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top