Examination of Immunosuppression Adjustment Impact on Kid... | NCT04104438

NCT04104438

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
basiliximab with Delayed TAC	Active Comparator	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	Drug: Basiliximab 20 MG
basiliximab, Delayed TAC with Everolimus	Active Comparator	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.	Drug: Basiliximab 20 MG
Control: standard TAC with steroids and MMF	No Intervention	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Basiliximab 20 MG	Drug	Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30	basiliximab with Delayed TAC

Measure	Description	Time Frame
Participants Who Have Recovered Renal Function	Assessment of dialysis independence (patients no longer requiring dialysis post LT)	6 months

Measure	Description	Time Frame
Cumulative Allograft Rejection	Liver biopsy-proven rejection	6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. A signed informed consent prior to patient participation in the study and before any assessment is performed.
2. Patients who are able to take oral medication.
3. 18 years old
4. Undergoing first OLT
5. Dialysis for 45 days or less at time of transplant
6. Able and willing to conform to requirements of the study
7. Able and willing to provide informed consent
  
  Exclusion Criteria:
1. < 18 years old
2. Autoimmune liver disease, Primary Sclerosing Cholangitis, Primary Biliary Cirrhosis
3. Dialysis greater than 45 days
4. Receiving ATG, IVIG therapy, or sirolimus/everolimus around time of transplant or sirolimus/everolimus after transplant
5. Unable to take oral medications
6. Participating in another clinical research study involving the evaluation of another investigational drug or device
7. Documented allergy to basiliximab, TAC, MMF or any macrolide antibiotic.
8. Presence of thrombosis of any major hepatic arteries
9. Complex/high risk arterial reconstruction at any time (graft vessel patency by Doppler ultrasound confirmed and documented).
10. Patients who are recipients of multiple solid organ transplants, (e.g., multivisceral or combined liver-kidney transplants), or have previously received an organ or tissue transplanted, or who received an ABO incompatible transplant.
11. Patients who have severe hypercholesterolemia (>215 mg/dL; >5.5 mmol/L) or hypertriglyceridemia (>265 mg/dL; >3.0 mmol/L) at Baseline.
12. Patients who have severe thrombocytopenia or neutropenia (platelet count >20 and MLCs>1000)
13. Patients who have any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study drugs
14. Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
15. Patients with clinically significant systemic infection
16. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive βHCG laboratory test (>9 mIU/mL) at Baseline.

Name	Affiliation	Role
Fady M Kaldas, MD	UCLA Dept Surgery	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
UCLA Medical Center		Los Angeles	California	90095	United States

Arm/Group Information

ID	Title	Description
FG000	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
FG001	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
FG002	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

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Participants Who Have Recovered Renal Function

Assessment of dialysis independence (patients no longer requiring dialysis post LT)

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	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

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 7, 2023	Sep 30, 2025	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Sep 3, 2020	Sep 30, 2025	SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	May 8, 2023	Nov 7, 2025	ICF_003.pdf

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins