Trial · NCT03020589
Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
NCT03020589, Phase 4, Completed, University of North Carolina, Chapel Hill; results first posted 2022-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients. Trials, record NCT03020589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03020589
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
- NCT number
- NCT03020589
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 97 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Renal Transplant
- Interventions
- Tacrolimus
- First posted
- 2017-01-13
- Last updated
- 2023-06-26
- Results first posted
- 2022-07-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation | Day 3 after transplantation | |
| Primary | Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 7 After Kidney Transplantation | Day 7 after transplantation | |
| Secondary | Number of Events of Biopsy Proven Acute Rejection (BPAR) | first 3 months (Days 0 through 90), 91-180, and 181-365 days after transplantation | The number of events of BPAR within the first 3 months (Days 0 through 90), 91-180, and 181-365 days after transplantation |
| Secondary | Tacrolimus Level | 4 months | Time to achieve tacrolimus therapeutic range at 0 to 4 months (8-10 ng/mL) |
| Secondary | Mean Number of Dose Adjustments and/or Drug Alterations | 12 months | Mean number of dose adjustments and/or drug alteration or addition due to insufficient immunosuppression. |
| Secondary | Percent of Participants With Chronic Renal Impairment by eGFR Category | 12 months | Renal function will be assessed using estimated Glomerular Filtration Rate (eGFR). Creatinine clearance (CrCl) may also be calculated as a reference. Patients will be categorized as having either mild (eGFR of 60 mL/min/1.73m\^2 to 89 mL/min/1.73m\^2), moderate (eGFR of 30 mL/min/1.73m\^2 to 59 mL/min/1.73m\^2), or severe renal impairment (eGFR \<30 mL/min/1.73m\^2). |
| Secondary | Number of Adverse Outcomes | 12 months | Number of adverse outcomes (i.e., graft loss, infection, and death) |
| Other | Direct and Indirect Costs | 12 months | Direct and indirect cost related to treatment and management kidney transplant recipients |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation | Day 3 after transplantation | proportion of participants | NUMBER | |
| PRIMARY | Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 7 After Kidney Transplantation | Day 7 after transplantation | Proportion of participants | NUMBER | |
| SECONDARY | Number of Events of Biopsy Proven Acute Rejection (BPAR) | first 3 months (Days 0 through 90), 91-180, and 181-365 days after transplantation | BPAR events | NUMBER | |
| SECONDARY | Tacrolimus Level | 4 months | Days | MEAN | |
| SECONDARY | Mean Number of Dose Adjustments and/or Drug Alterations | 12 months | Adjustments | MEAN | |
| SECONDARY | Percent of Participants With Chronic Renal Impairment by eGFR Category | 12 months | percentage of participants | NUMBER | |
| SECONDARY | Number of Adverse Outcomes | 12 months | adverse outcomes | NUMBER | |
| OTHER_PRE_SPECIFIED | Direct and Indirect Costs | 12 months |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation | CYP3A5 Based Tacrolimus Dosing | 0.2 | proportion of participants | ||
| Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 3 After Kidney Transplantation | Control | 0.14 | proportion of participants | ||
| Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 7 After Kidney Transplantation | CYP3A5 Based Tacrolimus Dosing | 0.29 | Proportion of participants | ||
| Proportion of Patients Reaching Target Tacrolimus Levels (8-10 ng/mL) on Day 7 After Kidney Transplantation | Control | 0.21 | Proportion of participants | ||
| Number of Events of Biopsy Proven Acute Rejection (BPAR) | CYP3A5 Based Tacrolimus Dosing | Days 0 through 90 | 3 | BPAR events | |
| Number of Events of Biopsy Proven Acute Rejection (BPAR) | Control | Days 0 through 90 | 2 | BPAR events | |
| Number of Events of Biopsy Proven Acute Rejection (BPAR) | CYP3A5 Based Tacrolimus Dosing | Days 91-180 | 3 | BPAR events | |
| Number of Events of Biopsy Proven Acute Rejection (BPAR) | Control | Days 91-180 | 0 | BPAR events | |
| Number of Events of Biopsy Proven Acute Rejection (BPAR) | CYP3A5 Based Tacrolimus Dosing | Days 181-365 | 0 | BPAR events | |
| Number of Events of Biopsy Proven Acute Rejection (BPAR) | Control | Days 181-365 | 0 | BPAR events |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CYP3A5 Based Tacrolimus Dosing | 40 | |
| Overall Study | STARTED | Control | 57 | |
| Overall Study | COMPLETED | CYP3A5 Based Tacrolimus Dosing | 40 | |
| Overall Study | COMPLETED | Control | 57 | |
| Overall Study | NOT COMPLETED | CYP3A5 Based Tacrolimus Dosing | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events46
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neurotoxicity | Nervous system disorders | CYP3A5 Based Tacrolimus Dosing | 3 | 40 | 5 |
| other | Neurotoxicity | Nervous system disorders | Control | 5 | 57 | 5 |
| other | Tremor | Nervous system disorders | CYP3A5 Based Tacrolimus Dosing | 10 | 40 | 12 |
| other | Tremor | Nervous system disorders | Control | 22 | 57 | 25 |
| other | Headache | Nervous system disorders | CYP3A5 Based Tacrolimus Dosing | 11 | 40 | 16 |
| other | Headache | Nervous system disorders | Control | 21 | 57 | 26 |
| other | Diarrhea | Gastrointestinal disorders | CYP3A5 Based Tacrolimus Dosing | 12 | 40 | 16 |
| other | Diarrhea | Gastrointestinal disorders | Control | 22 | 57 | 37 |
| other | Nausea | Gastrointestinal disorders | CYP3A5 Based Tacrolimus Dosing | 12 | 40 | 26 |
| other | Nausea | Gastrointestinal disorders | Control | 21 | 57 | 28 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CYP3A5 Based Tacrolimus Dosing | 1 | 40 |
| Total, all-cause mortality | Control | 0 | 57 |
| Total, other adverse events | CYP3A5 Based Tacrolimus Dosing | 40 | 40 |
| Total, other adverse events | Control | 57 | 57 |
| Total, serious adverse events | CYP3A5 Based Tacrolimus Dosing | 4 | 40 |
| Total, serious adverse events | Control | 2 | 57 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CYP3A5 Based Tacrolimus Dosing vs Control: deaths from any cause | Trial comparisons |
| CYP3A5 Based Tacrolimus Dosing vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03020589
GET https://conductscience.org/api/trials/v1/NCT03020589/results?page=2