Trial Outcomes & Findings for Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function (NCT NCT04258423)

NCT ID: NCT04258423

Last Updated: 2023-05-24

Results Overview

Glomerular Filtration Rate

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 4 participants
• Primary outcome timeframe: 36 months post-transplant
• Results posted on: 2023-05-24

Participant Flow

Participant milestones

Measure	Control Arm Tacrolimus as maintenance immunosuppression Tacrolimus: Low dose Tacrolimus (FK / Prograf®) (titrated to a goal trough of 5 ± 1 ng/mL)	Study Arm Everolimus as maintenance immunosuppression Everolimus: Everolimus (target trough levels 4-8 ng/mL) initiated at 1mg BID. Tacrolimus will be discontinued once Everolimus level is within goal or at the discretion of the provider
Overall Study STARTED	2	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Control Arm Tacrolimus as maintenance immunosuppression Tacrolimus: Low dose Tacrolimus (FK / Prograf®) (titrated to a goal trough of 5 ± 1 ng/mL)	Study Arm Everolimus as maintenance immunosuppression Everolimus: Everolimus (target trough levels 4-8 ng/mL) initiated at 1mg BID. Tacrolimus will be discontinued once Everolimus level is within goal or at the discretion of the provider
Overall Study Study Closure	2	2

Baseline Characteristics

Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function

Baseline characteristics by cohort

Measure	Control Arm n=2 Participants Tacrolimus as maintenance immunosuppression Tacrolimus: Low dose Tacrolimus	Study Arm n=2 Participants Everolimus as maintenance immunosuppression Everolimus: Everolimus	Total n=4 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	60 Years n=5 Participants	61 Years n=7 Participants	60.5 Years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	2 participants n=5 Participants	2 participants n=7 Participants	4 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

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.

Biopsy

Outcome measures

Outcome data not reported

Adverse Events

Control Arm

Serious events: 0 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=2 participants at risk Tacrolimus as maintenance immunosuppression Tacrolimus: Low dose Tacrolimus	Study Arm n=2 participants at risk Everolimus as maintenance immunosuppression Everolimus: Everolimus
Blood and lymphatic system disorders Anemia	0.00% 0/2 • 6 Months	50.0% 1/2 • Number of events 1 • 6 Months

Other adverse events

Adverse event data not reported

Additional Information

Dr. 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