Trial Outcomes & Findings for Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant (NCT NCT04104438)
NCT ID: NCT04104438
Last Updated: 2025-12-16
Results Overview
Assessment of dialysis independence (patients no longer requiring dialysis post LT)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
6 months
Results posted on
2025-12-16
Participant Flow
Participant milestones
| Measure |
Basiliximab With Delayed TAC
Basiliximab
* Dose #1: 20mg IV within 2 hours of transplant
* Dose #2: 20mg IV Post-operative day #4
Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
Post-operative taper:
* Post-op day 1- methylprednisolone 50mg IVP Q6H
* Post-op day 2- methylprednisolone 40mg IVP Q6H
* Post-op day 3- methylprednisolone 30mg IVP Q6H
* Post-op day 4- methylprednisolone 20mg IVP Q6H
* Post-op day 5- methylprednisolone 20mg IVP Q12H
* Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Basliximab, Delayed TAC With Everolimus
Basiliximab
Tacrolimus (with basiliximab induction)
o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated
Corticosteroids (SOC): Per UCLA protocol
Everolimus (delayed)
o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Control: Standard TAC With Steroids and MMF
Tacrolimus (without basiliximab induction)
* Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL
* Six months to one year: maintain whole blood trough concentration of 5-10ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
13
|
|
Overall Study
COMPLETED
|
28
|
20
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
8
|
2
|
Reasons for withdrawal
| Measure |
Basiliximab With Delayed TAC
Basiliximab
* Dose #1: 20mg IV within 2 hours of transplant
* Dose #2: 20mg IV Post-operative day #4
Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
Post-operative taper:
* Post-op day 1- methylprednisolone 50mg IVP Q6H
* Post-op day 2- methylprednisolone 40mg IVP Q6H
* Post-op day 3- methylprednisolone 30mg IVP Q6H
* Post-op day 4- methylprednisolone 20mg IVP Q6H
* Post-op day 5- methylprednisolone 20mg IVP Q12H
* Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Basliximab, Delayed TAC With Everolimus
Basiliximab
Tacrolimus (with basiliximab induction)
o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated
Corticosteroids (SOC): Per UCLA protocol
Everolimus (delayed)
o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Control: Standard TAC With Steroids and MMF
Tacrolimus (without basiliximab induction)
* Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL
* Six months to one year: maintain whole blood trough concentration of 5-10ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
1
|
2
|
|
Overall Study
Adverse Event
|
0
|
3
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
|
Overall Study
Disenrolled due to noncompliance
|
0
|
1
|
0
|
|
Overall Study
stopped due to possible operation
|
0
|
1
|
0
|
|
Overall Study
everolimus not started due to bile duct injury
|
0
|
1
|
0
|
Baseline Characteristics
Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant
Baseline characteristics by cohort
| Measure |
Basiliximab With Delayed TAC
n=30 Participants
Basiliximab
* Dose #1: 20mg IV within 2 hours of transplant
* Dose #2: 20mg IV Post-operative day #4
Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
Post-operative taper:
* Post-op day 1- methylprednisolone 50mg IVP Q6H
* Post-op day 2- methylprednisolone 40mg IVP Q6H
* Post-op day 3- methylprednisolone 30mg IVP Q6H
* Post-op day 4- methylprednisolone 20mg IVP Q6H
* Post-op day 5- methylprednisolone 20mg IVP Q12H
* Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Basliximab, Delayed TAC With Everolimus
n=28 Participants
Basiliximab
Tacrolimus (with basiliximab induction)
o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated
Corticosteroids (SOC): Per UCLA protocol
Everolimus (delayed)
o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Control: Standard TAC With Steroids and MMF
n=13 Participants
Tacrolimus (without basiliximab induction)
* Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL
* Six months to one year: maintain whole blood trough concentration of 5-10ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
32 Participants
n=205 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=9 Participants
|
23 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
55 Participants
n=205 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
16 Participants
n=205 Participants
|
|
Age, Continuous
|
55 years
n=9 Participants
|
55 years
n=6 Participants
|
59 years
n=9 Participants
|
56 years
n=205 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=9 Participants
|
15 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
39 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
7 Participants
n=9 Participants
|
45 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=9 Participants
|
10 Participants
n=6 Participants
|
6 Participants
n=9 Participants
|
25 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Other race
|
20 Participants
n=9 Participants
|
18 Participants
n=6 Participants
|
8 Participants
n=9 Participants
|
46 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
3 Participants
n=9 Participants
|
4 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
5 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
14 Participants
n=205 Participants
|
|
Race/Ethnicity, Customized
More than 1 race
|
2 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=9 Participants
|
28 participants
n=6 Participants
|
13 participants
n=9 Participants
|
71 participants
n=205 Participants
|
PRIMARY outcome
Timeframe: 6 monthsAssessment of dialysis independence (patients no longer requiring dialysis post LT)
Outcome measures
| Measure |
Basiliximab With Delayed TAC
n=28 Participants
Basiliximab
* Dose #1: 20mg IV within 2 hours of transplant
* Dose #2: 20mg IV Post-operative day #4
Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
Post-operative taper:
* Post-op day 1- methylprednisolone 50mg IVP Q6H
* Post-op day 2- methylprednisolone 40mg IVP Q6H
* Post-op day 3- methylprednisolone 30mg IVP Q6H
* Post-op day 4- methylprednisolone 20mg IVP Q6H
* Post-op day 5- methylprednisolone 20mg IVP Q12H
* Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Basliximab, Delayed TAC With Everolimus
n=20 Participants
Basiliximab
Tacrolimus (with basiliximab induction)
o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated
Corticosteroids (SOC): Per UCLA protocol
Everolimus (delayed)
o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Control: Standard TAC With Steroids and MMF
n=11 Participants
Tacrolimus (without basiliximab induction)
* Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL
* Six months to one year: maintain whole blood trough concentration of 5-10ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
|
|---|---|---|---|
|
Participants Who Have Recovered Renal Function
|
28 Participants
|
20 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsLiver biopsy-proven rejection
Outcome measures
| Measure |
Basiliximab With Delayed TAC
n=28 Participants
Basiliximab
* Dose #1: 20mg IV within 2 hours of transplant
* Dose #2: 20mg IV Post-operative day #4
Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
Post-operative taper:
* Post-op day 1- methylprednisolone 50mg IVP Q6H
* Post-op day 2- methylprednisolone 40mg IVP Q6H
* Post-op day 3- methylprednisolone 30mg IVP Q6H
* Post-op day 4- methylprednisolone 20mg IVP Q6H
* Post-op day 5- methylprednisolone 20mg IVP Q12H
* Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Basliximab, Delayed TAC With Everolimus
n=20 Participants
Basiliximab
Tacrolimus (with basiliximab induction)
o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated
Corticosteroids (SOC): Per UCLA protocol
Everolimus (delayed)
o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Control: Standard TAC With Steroids and MMF
n=11 Participants
Tacrolimus (without basiliximab induction)
* Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL
* Six months to one year: maintain whole blood trough concentration of 5-10ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
|
|---|---|---|---|
|
Cumulative Allograft Rejection
|
2 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Basiliximab With Delayed TAC
Serious events: 14 serious events
Other events: 14 other events
Deaths: 2 deaths
Basliximab, Delayed TAC With Everolimus
Serious events: 7 serious events
Other events: 18 other events
Deaths: 1 deaths
Control: Standard TAC With Steroids and MMF
Serious events: 1 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Basiliximab With Delayed TAC
n=30 participants at risk
Basiliximab
* Dose #1: 20mg IV within 2 hours of transplant
* Dose #2: 20mg IV Post-operative day #4
Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
Post-operative taper:
* Post-op day 1- methylprednisolone 50mg IVP Q6H
* Post-op day 2- methylprednisolone 40mg IVP Q6H
* Post-op day 3- methylprednisolone 30mg IVP Q6H
* Post-op day 4- methylprednisolone 20mg IVP Q6H
* Post-op day 5- methylprednisolone 20mg IVP Q12H
* Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Basliximab, Delayed TAC With Everolimus
n=28 participants at risk
Basiliximab
Tacrolimus (with basiliximab induction)
o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated
Corticosteroids (SOC): Per UCLA protocol
Everolimus (delayed)
o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Control: Standard TAC With Steroids and MMF
n=13 participants at risk
Tacrolimus (without basiliximab induction)
* Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL
* Six months to one year: maintain whole blood trough concentration of 5-10ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
Nausea/Vomiting
|
6.7%
2/30 • 6 months
|
0.00%
0/28 • 6 months
|
7.7%
1/13 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
2/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
Weakness
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
Fever
|
10.0%
3/30 • 6 months
|
10.7%
3/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Renal and urinary disorders
UTI
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • 6 months
|
7.7%
1/13 • 6 months
|
|
Renal and urinary disorders
Hyperkalemia
|
3.3%
1/30 • 6 months
|
7.1%
2/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Hepatobiliary disorders
encepahlopathy
|
3.3%
1/30 • 6 months
|
7.1%
2/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Renal and urinary disorders
kidney stone
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
dysphagia
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
stroke
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Hepatobiliary disorders
bile duct stricture
|
0.00%
0/30 • 6 months
|
0.00%
0/28 • 6 months
|
7.7%
1/13 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pyothorax
|
0.00%
0/30 • 6 months
|
0.00%
0/28 • 6 months
|
7.7%
1/13 • 6 months
|
Other adverse events
| Measure |
Basiliximab With Delayed TAC
n=30 participants at risk
Basiliximab
* Dose #1: 20mg IV within 2 hours of transplant
* Dose #2: 20mg IV Post-operative day #4
Tacrolimus (with basiliximab induction) o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to six months: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
Post-operative taper:
* Post-op day 1- methylprednisolone 50mg IVP Q6H
* Post-op day 2- methylprednisolone 40mg IVP Q6H
* Post-op day 3- methylprednisolone 30mg IVP Q6H
* Post-op day 4- methylprednisolone 20mg IVP Q6H
* Post-op day 5- methylprednisolone 20mg IVP Q12H
* Post-op day 6- methylprednisolone 10mg IVP Q12H until taking PO, then change to: prednisone 20mg PO QAM
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Basliximab, Delayed TAC With Everolimus
n=28 participants at risk
Basiliximab
Tacrolimus (with basiliximab induction)
o Beginning day #5 post-transplant or when SCr \< 1.8 mg/dl (subjects off dialysis) to POD 30: 0.03-0.1mg/kg q12h PO to maintain whole blood trough concentration of 4-6ng/mL
Mycophenolate mofetil o 1000 mg po bid up to POD 30: reduce mycophenolate mofetil following achievement of steady state everolimus (POD 35) as clinically indicated
Corticosteroids (SOC): Per UCLA protocol
Everolimus (delayed)
o Add by POD 30: 1 mg po bid and adjusted to maintain whole blood trough concentrations of 3-8 ng/ml.
Basiliximab 20 MG: Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
|
Control: Standard TAC With Steroids and MMF
n=13 participants at risk
Tacrolimus (without basiliximab induction)
* Beginning day #1 post-transplant to six months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 5-12ng/mL
* Six months to one year: maintain whole blood trough concentration of 5-10ng/mL
Mycophenolate mofetil
o 1000 mg po bid
Corticosteroids (SOC): Per UCLA protocol
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
hand/wrist pain
|
0.00%
0/30 • 6 months
|
0.00%
0/28 • 6 months
|
15.4%
2/13 • 6 months
|
|
General disorders
chest pain
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
7.7%
1/13 • 6 months
|
|
General disorders
wound healing delay
|
0.00%
0/30 • 6 months
|
0.00%
0/28 • 6 months
|
7.7%
1/13 • 6 months
|
|
Renal and urinary disorders
hyperkalemia
|
3.3%
1/30 • 6 months
|
3.6%
1/28 • 6 months
|
15.4%
2/13 • 6 months
|
|
General disorders
hypotension
|
0.00%
0/30 • 6 months
|
0.00%
0/28 • 6 months
|
7.7%
1/13 • 6 months
|
|
General disorders
abdominal pain
|
3.3%
1/30 • 6 months
|
17.9%
5/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Gastrointestinal disorders
diarrhea
|
3.3%
1/30 • 6 months
|
7.1%
2/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
insomnia
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
nausea
|
3.3%
1/30 • 6 months
|
10.7%
3/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
3.3%
1/30 • 6 months
|
3.6%
1/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
Lower extremity edema
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
fatigue
|
3.3%
1/30 • 6 months
|
10.7%
3/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
sore throat
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
anemia
|
10.0%
3/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
dizziness
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Blood and lymphatic system disorders
neutropenia
|
6.7%
2/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
General disorders
tingling
|
3.3%
1/30 • 6 months
|
0.00%
0/28 • 6 months
|
0.00%
0/13 • 6 months
|
|
Gastrointestinal disorders
Indigestion
|
0.00%
0/30 • 6 months
|
0.00%
0/28 • 6 months
|
7.7%
1/13 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place