Trial Outcomes & Findings for Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation (NCT NCT02123108)

NCT ID: NCT02123108

Last Updated: 2022-09-29

Results Overview

Number of participants who experienced dialysis independence or improvement based upon kidney function labs as a measure of renal recovery/ function following OLT in patients after undergoing orthotopic liver transplant

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 59 participants
• Primary outcome timeframe: 12 months post-transplant
• Results posted on: 2022-09-29

Participant Flow

Participant milestones

Measure	Basiliximab Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Tacrolimus Group Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
Overall Study STARTED	30	29
Overall Study COMPLETED	28	26
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Basiliximab Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Tacrolimus Group Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
Overall Study Death	2	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Basiliximab n=30 Participants Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Tacrolimus Group n=29 Participants Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Total n=59 Participants Total of all reporting groups
Age, Continuous	59 years n=30 Participants	56.7 years n=29 Participants	57.9 years n=59 Participants
Sex: Female, Male Female	11 Participants n=30 Participants	21 Participants n=29 Participants	32 Participants n=59 Participants
Sex: Female, Male Male	19 Participants n=30 Participants	8 Participants n=29 Participants	27 Participants n=59 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants	29 participants n=29 Participants	59 participants n=59 Participants

PRIMARY outcome

Timeframe: 12 months post-transplant

Number of participants who experienced dialysis independence or improvement based upon kidney function labs as a measure of renal recovery/ function following OLT in patients after undergoing orthotopic liver transplant

Outcome measures

Measure	Tacrolimus Group n=26 Participants Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Basiliximab n=28 Participants Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
Renal Recovery/ Function	26 Participants	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post liver transplantation

Outcome measures

Measure	Tacrolimus Group n=29 Participants Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Basiliximab n=30 Participants Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
Participants Experiencing Adverse Event Attributable to Study Drug	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post liver transplant

Outcome measures

Measure	Tacrolimus Group n=29 Participants Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Basiliximab n=30 Participants Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
Participants Experiencing Acute Rejection Episode	4 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post liver transplant

Participants at risk minus incidence of death within the first year post-transplant

Outcome measures

Measure	Tacrolimus Group n=29 Participants Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Basiliximab n=30 Participants Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
Survival	26 Participants	28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months post transplant

Outcome measures

Measure	Tacrolimus Group n=29 Participants Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Basiliximab n=30 Participants Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
Participants Experiencing Graft Failure	5 Participants	2 Participants

Adverse Events

Basiliximab

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

Tacrolimus Group

Serious events: 3 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Basiliximab n=30 participants at risk Tacrolimus with Basiliximab induction Basiliximab: Peri-operative 40 mg IV dose within 4 hours of OLT Postoperative 20mg IV dose Day 4 Tacrolimus: Day #7 post-transplant or when serum creatinine (SCr) \< 1.8 mg/dl 6 months to 1 year: 0.03-0.1 mg.kg q12h po to maintain whole blood trough concentration of 3-5ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid	Tacrolimus Group n=29 participants at risk Tacrolimus (without basiliximab induction); standard of care group Tacrolimus: Day #1 post-transplant to 6 months: 0.03-0.1mg/kg q12h po to maintain whole blood trough concentration of 7-10 ng/mL + 6 months to 1 year: maintain whole blood trough concentration of 5-8ng/mL Mycophenolic Acid: Enteric coated mycophenolic acid 360-720 mg po bid
General disorders Death	6.7% 2/30 • Number of events 2 • 12 months	10.3% 3/29 • Number of events 3 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Fady M. Kaldas

University of California Los Angeles

Phone: 310-825-8138

Email: FKaldas@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place