Trial Outcomes & Findings for Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation (NCT NCT02736227)
NCT ID: NCT02736227
Last Updated: 2022-10-07
Results Overview
flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
28 participants
Primary outcome timeframe
Six months post transplantation
Results posted on
2022-10-07
Participant Flow
From May 2016 to May 2018, 170 adult primary LT were performed at our center. 20 Subjects underwent tac (Tacrolimus)withdrwal. 28 patients consented but 8 were removed Final sample for analysis is n=20
28 patients consented but 8 were removed (n=1 withdrew, n=2 non compliant with protocol, n=2 new wound issues, n=1 high urine protein/creatinine ration and n=2 had neutropenia) Final sample for analysis is n=20
Participant milestones
| Measure |
Graft Rejection After Tacrolimus Was Discontinued (REJ)
Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6
|
No Graft Rejection After Tacrolimus Weaning (Non REJ)
NON-REJ patients did not required liver biopsy during the trial
|
Removed From Study Before Tac Withdrawl Started
Removed from study before Tac withdrawl started
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
15
|
8
|
|
Overall Study
COMPLETED
|
5
|
15
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
8
|
Reasons for withdrawal
| Measure |
Graft Rejection After Tacrolimus Was Discontinued (REJ)
Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6
|
No Graft Rejection After Tacrolimus Weaning (Non REJ)
NON-REJ patients did not required liver biopsy during the trial
|
Removed From Study Before Tac Withdrawl Started
Removed from study before Tac withdrawl started
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
5
|
|
Overall Study
Non Compliant
|
0
|
0
|
2
|
Baseline Characteristics
no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
Baseline characteristics by cohort
| Measure |
Graft Rejection After Tacrolimus Was Discontinued (REJ)
n=5 Participants
Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6
|
No Graft Rejection After Tacrolimus Weaning (Non REJ)
n=15 Participants
NON-REJ patients did not required liver biopsy during the trial
|
Withdrew From Study Before Tacrolimus Weaning
n=8 Participants
These subjects were removed after consenting. These subjects were not initiated on TAC weaning
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.4 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 6.8 • n=15 Participants
|
56 years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
61.1 years
STANDARD_DEVIATION 7.1 • n=28 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=15 Participants
|
2 Participants
n=8 Participants
|
8 Participants
n=28 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=15 Participants
|
6 Participants
n=8 Participants
|
20 Participants
n=28 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
8 Participants
n=8 Participants
|
28 Participants
n=28 Participants
|
|
Hepatocellular Carcinoma
|
3 participants
n=5 Participants • no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
4 participants
n=15 Participants • no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
7 participants
n=20 Participants • no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Primary Liver Disease- Hep C
|
3 participants
n=5 Participants
|
2 participants
n=15 Participants
|
0 participants
n=8 Participants
|
5 participants
n=28 Participants
|
|
Primary Liver Disease- Alcohol
|
1 participants
n=5 Participants
|
5 participants
n=15 Participants
|
0 participants
n=8 Participants
|
6 participants
n=28 Participants
|
|
Primary Liver Disease- Non Alcoholic Fatty Liver
|
1 participants
n=5 Participants
|
4 participants
n=15 Participants
|
0 participants
n=8 Participants
|
5 participants
n=28 Participants
|
|
Primary Liver Disease- Other
|
0 participants
n=5 Participants
|
4 participants
n=15 Participants
|
0 participants
n=8 Participants
|
4 participants
n=28 Participants
|
|
Tacrolimus Trough
|
5.4 ng/ml
STANDARD_DEVIATION 0.8 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
5.2 ng/ml
STANDARD_DEVIATION 1.4 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
5.2 ng/ml
STANDARD_DEVIATION 1.3 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Everolimus Trough
|
5.3 ng/ml
STANDARD_DEVIATION 1.2 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
5.3 ng/ml
STANDARD_DEVIATION 2.3 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
5.3 ng/ml
STANDARD_DEVIATION 2.1 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -White Blood Count
|
5.6 1000 *cells*/mm^3
STANDARD_DEVIATION 1.9 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
3.7 1000 *cells*/mm^3
STANDARD_DEVIATION 1.7 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
4.2 1000 *cells*/mm^3
STANDARD_DEVIATION 1.9 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -Hb
|
11.9 g/dl
STANDARD_DEVIATION 1.1 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
10.7 g/dl
STANDARD_DEVIATION 2.5 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
11 g/dl
STANDARD_DEVIATION 2.3 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -Platelet count
|
144.6 1000 *cells*/mm^3
STANDARD_DEVIATION 47.6 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
111.9 1000 *cells*/mm^3
STANDARD_DEVIATION 59.2 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
119.7 1000 *cells*/mm^3
STANDARD_DEVIATION 57.3 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -eGFR-MDRD
|
55.2 mL/min/1.73 m^2
STANDARD_DEVIATION 15.6 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
60.3 mL/min/1.73 m^2
STANDARD_DEVIATION 17.7 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
59 mL/min/1.73 m^2
STANDARD_DEVIATION 17 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -Total Bilirubin
|
0.36 mg/dl
STANDARD_DEVIATION 0.1 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
0.8 mg/dl
STANDARD_DEVIATION 0.8 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
0.7 mg/dl
STANDARD_DEVIATION 0.7 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -AST
|
23.6 u/l
STANDARD_DEVIATION 5.4 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
15.4 u/l
STANDARD_DEVIATION 6.9 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
17.3 u/l
STANDARD_DEVIATION 7.4 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -ALT
|
28.2 u/l
STANDARD_DEVIATION 6.3 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
19.1 u/l
STANDARD_DEVIATION 7.3 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
21.3 u/l
STANDARD_DEVIATION 8 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
|
Lab Value -Alk Phos
|
95.2 u/l
STANDARD_DEVIATION 47.7 • n=5 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
69.9 u/l
STANDARD_DEVIATION 24.6 • n=15 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
—
|
75.9 u/l
STANDARD_DEVIATION 32.1 • n=20 Participants • Measure Analysis Population Description: no participants contributed data for the "Withdrew from study before Tacrolimus weaning"
|
PRIMARY outcome
Timeframe: Six months post transplantationPopulation: 15 patients did not reject and 5 had mild rejection responding to tacrolimus resumption.
flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal)
Outcome measures
| Measure |
Graft Rejection After Tacrolimus Was Discontinued (REJ)
n=5 Participants
Incidence of Acute Rejection after the initiation of Tacrolimus Withdrawl at Month 3 and 6
|
No Graft Rejection After Tacrolimus Weaning (Non REJ)
n=15 Participants
NON-REJ patients did not required liver biopsy during the trial
|
|---|---|---|
|
Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection
|
10 percentage of CD4 positive cell
Standard Deviation 1
|
5 percentage of CD4 positive cell
Standard Deviation .2
|
Adverse Events
Graft Rejection After Tacrolimus Was Discontinued (REJ)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Graft Rejection After Tacrolimus Weaning (Non REJ)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Withdrew From Study Before Tacrolimus Weaning
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place