Trial Outcomes & Findings for Steroid Free Immunosuppression in Liver Transplantation (NCT NCT00296244)

Results Overview

Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

1 and 2 years

Results posted on

2012-11-19

Participant Flow

Between February 2006 and November 2007,at Thomas Jefferson University, 40 adult orthotopic liver transplantation recipients were enrolled in the study and 20 recipients were randomized in each group.

One recipient in the Steroid free group required re-transplantation and died within 1 month after the 2nd OLT, and was subsequently excluded from analysis.

Participant milestones

Participant milestones
Measure	Control Group Control group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)with steroids	Study Group Study group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Control group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)with steroids	Study Group Study group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)
Overall Study Underwent retransplant	0	1

Baseline Characteristics

Steroid Free Immunosuppression in Liver Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=20 Participants Control group -basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=20 Participants Study group- basiliximab, tacrolimus, EC-MPA	Total n=40 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	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age Continuous	50.40 years STANDARD_DEVIATION 2.6 • n=5 Participants	56.2 years STANDARD_DEVIATION 1.1 • n=7 Participants	53 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 and 2 years

Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants Control group-basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=19 Participants Study group- basiliximab, tacrolimus, EC-MPA
Graft Survival Rate 1-year graft survival rate	100 percentage of participants	94.7 percentage of participants
Graft Survival Rate 2-year graft survival rate	90 percentage of participants	84 percentage of participants

PRIMARY outcome

Timeframe: 1 and 2 years

Percentage of recipients who are still alive at the end of 1 and 2 years.

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants Control group-basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=19 Participants Study group- basiliximab, tacrolimus, EC-MPA
Patient Survival Rate 1-year patient survival rate	100 Percentage of participants	94.7 Percentage of participants
Patient Survival Rate 2-year patient survival rate	90 Percentage of participants	84 Percentage of participants

PRIMARY outcome

Timeframe: 6 months post-transplant

Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants Control group-basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=19 Participants Study group- basiliximab, tacrolimus, EC-MPA
Acute Rejection Rate	5 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: 3 months post-transplant

Incidence of bacterial infection was similar in the control group as well as study group, 4 patients in both groups had infection

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants Control group-basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=19 Participants Study group- basiliximab, tacrolimus, EC-MPA
Infection as an Adverse Effect of Steroids	20 Percentage of participants	21 Percentage of participants

SECONDARY outcome

Timeframe: 6 months post-transplant

Population: Only patients with HCV cirrhosis as the main indication for OLT were included in this analysis

The incidence and severity of HCV recurrence based on Hepatitis C PCR levels and protocol liver biopsy findings were found to be similar between the 2 groups.

Outcome measures

Outcome measures
Measure	Control Group n=11 Participants Control group-basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=14 Participants Study group- basiliximab, tacrolimus, EC-MPA
Incidence and Severity of HCV Recurrence Post-OLT	27 Percentage of participants	29 Percentage of participants

SECONDARY outcome

Timeframe: 6 months

The incidence of new-onset Diabetes mellitus (NODM, based on percentage of previously non-diabetic patients who developed DM post-transplantation, was similar between the 2 groups.

Outcome measures

Outcome measures
Measure	Control Group n=20 Participants Control group-basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=19 Participants Study group- basiliximab, tacrolimus, EC-MPA
New-onset Diabetes Mellitus (NODM) as Secondary Outcome	40 Percentage of participants	42 Percentage of participants

Adverse Events

Control Group

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Study Group

Serious events: 3 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=20 participants at risk Control group -basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=19 participants at risk Study group- basiliximab, tacrolimus, EC-MPA
General disorders Death	10.0% 2/20 • Number of events 2 • Adverse data were collected at 1 and 2 years follow-up.	15.8% 3/19 • Number of events 3 • Adverse data were collected at 1 and 2 years follow-up.

Other adverse events

Other adverse events
Measure	Control Group n=20 participants at risk Control group -basiliximab, tacrolimus, EC-MPA, steroids	Study Group n=19 participants at risk Study group- basiliximab, tacrolimus, EC-MPA
Immune system disorders Acute rejection	5.0% 1/20 • Number of events 1 • Adverse data were collected at 1 and 2 years follow-up.	5.3% 1/19 • Number of events 1 • Adverse data were collected at 1 and 2 years follow-up.
Infections and infestations Infection	20.0% 4/20 • Number of events 4 • Adverse data were collected at 1 and 2 years follow-up.	21.1% 4/19 • Number of events 4 • Adverse data were collected at 1 and 2 years follow-up.
Endocrine disorders New-onset Diabetes Mellitus (NODM)	40.0% 8/20 • Number of events 8 • Adverse data were collected at 1 and 2 years follow-up.	42.1% 8/19 • Number of events 8 • Adverse data were collected at 1 and 2 years follow-up.
Hepatobiliary disorders Hepatitis C Recurrence	27.3% 3/11 • Number of events 3 • Adverse data were collected at 1 and 2 years follow-up.	28.6% 4/14 • Number of events 4 • Adverse data were collected at 1 and 2 years follow-up.

Additional Information

Carlo Gerardo B Ramirez, MD

Thomas Jefferson University

Phone: 215-955-5909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place