Trial Outcomes & Findings for Everolimus Monotherapy as Immunosuppression After Liver Transplant (NCT NCT04063865)

NCT ID: NCT04063865

Last Updated: 2023-05-23

Results Overview

Glomerular Filtration Rate

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 14 participants
• Primary outcome timeframe: 36 months post-transplant
• Results posted on: 2023-05-23

Participant Flow

Participant milestones

Measure	Control Arm Tacrolimus as maintenance immunosuppression Tacrolimus: Tacrolimus (FK / Prograf) titrated to a goal trough of 6 - 8 ng/ml	Study Arm Everolimus monotherapy maintenance immunosuppression Everolimus: Everolimus (target trough levels 4 - 8 ng/mL) + low dose Tacrolimus (target trough levels 3-5 ng/mL)
Overall Study STARTED	6	8
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	8

Reasons for withdrawal

Measure	Control Arm Tacrolimus as maintenance immunosuppression Tacrolimus: Tacrolimus (FK / Prograf) titrated to a goal trough of 6 - 8 ng/ml	Study Arm Everolimus monotherapy maintenance immunosuppression Everolimus: Everolimus (target trough levels 4 - 8 ng/mL) + low dose Tacrolimus (target trough levels 3-5 ng/mL)
Overall Study Physician Decision	1	3
Overall Study Study Closed Prior to Completion	4	4
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Everolimus Monotherapy as Immunosuppression After Liver Transplant

Baseline characteristics by cohort

Measure	Control Arm n=6 Participants Tacrolimus as maintenance immunosuppression Tacrolimus: Tacrolimus (FK / Prograf) titrated to a goal trough of 6 - 8 ng/ml	Study Arm n=8 Participants Everolimus monotherapy maintenance immunosuppression Everolimus: Everolimus monotherapy - target trough levels 4 - 8 ng/ml as maintenance immunosuppression	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	51.33 Years n=5 Participants	57.5 Years n=7 Participants	54.86 Years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months post-transplant

Population: Study was terminated prior to any subject reaching the 36 Month timepoint. No data were collected for this outcome measure.

Glomerular Filtration Rate

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 36 months post-transplant

Population: Study was terminated prior to any subject reaching the 36 Month timepoint. No data were collected for this outcome measure.

Glomerular Filtration Rate

Outcome measures

Outcome data not reported

Adverse Events

Control Arm

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Study Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Arm n=6 participants at risk Tacrolimus as maintenance immunosuppression Tacrolimus: Tacrolimus (FK / Prograf) titrated to a goal trough of 6 - 8 ng/ml	Study Arm n=8 participants at risk Everolimus monotherapy maintenance immunosuppression Everolimus: Everolimus monotherapy - target trough levels 4 - 8 ng/ml as maintenance immunosuppression
Respiratory, thoracic and mediastinal disorders Lung Infection	0.00% 0/6 • 1 year, 2 months AEs were collected from each participant for up to 14 months since the study was terminated prior to completion.	12.5% 1/8 • Number of events 1 • 1 year, 2 months AEs were collected from each participant for up to 14 months since the study was terminated prior to completion.
Hepatobiliary disorders Liver Infection	16.7% 1/6 • Number of events 1 • 1 year, 2 months AEs were collected from each participant for up to 14 months since the study was terminated prior to completion.	0.00% 0/8 • 1 year, 2 months AEs were collected from each participant for up to 14 months since the study was terminated prior to completion.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	16.7% 1/6 • Number of events 1 • 1 year, 2 months AEs were collected from each participant for up to 14 months since the study was terminated prior to completion.	0.00% 0/8 • 1 year, 2 months AEs were collected from each participant for up to 14 months since the study was terminated prior to completion.

Other adverse events

Adverse event data not reported

Additional Information

Chandrashekhar Kubal

Indiana University

Phone: 317-312-2601

Email: sakubal@iupui.edu

Results disclosure agreements

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