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=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
60 Years
n=99 Participants
|
61 Years
n=107 Participants
|
60.5 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 36 months post-transplantPopulation: 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-transplantPopulation: 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-transplantPopulation: 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place