Trial Outcomes & Findings for Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients (NCT NCT00374231)

NCT ID: NCT00374231

Last Updated: 2015-12-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2015-12-29

Participant Flow

From 3/2003 to 11/2005 forty adult deceased donor liver transplant recipients were enrolled. Subjects were eligible once they were greater than 90 days post liver transplant provided they had a 30 day rejection free period prior to enrollment.

Participant milestones

Measure	Corticosteroid Withdrawal Discontinue prednisone at 90 days or longer post liver transplant if rejection free previous 30 days.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients

Baseline characteristics by cohort

Measure	Tacrolimus and Mycophenolate Mofetil n=40 Participants All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Cause of Liver Disease Alcoholic Liver Disease	9 participants n=5 Participants
Cause of Liver Disease Viral Hepatitis C	6 participants n=5 Participants
Cause of Liver Disease Primary Schlerosing Cholangitis	6 participants n=5 Participants
Cause of Liver Disease Hepatocellular Carcinoma	6 participants n=5 Participants
Cause of Liver Disease Cryptogenic Cirrhosis	6 participants n=5 Participants
Cause of Liver Disease Non-alcholic Steatohepatitis	2 participants n=5 Participants
Cause of Liver Disease Autoimmune Hepatitis	1 participants n=5 Participants
Cause of Liver Disease Other	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure

Corticosteroid Withdrawa. n=40 Participants All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Incidence of Biopsy Confirmed Acute Rejection at 12 Months.

5 participants

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure

Corticosteroid Withdrawa. n=40 Participants All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Patient Survival.

39 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

The mean days from post transplant corticosteroid withdrawal.

Outcome measures

Measure

Corticosteroid Withdrawa. n=40 Participants All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Time Post Transplant Corticosteroid Withdrawal

257 days Standard Deviation 511

Adverse Events

Tacrolimus and Mycophenolate Mofetil

Serious events: 9 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tacrolimus and Mycophenolate Mofetil n=40 participants at risk All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.
Infections and infestations Lower Extremity Cellulites	2.5% 1/40 • Number of events 1 • 2 years
Nervous system disorders Acute Cerebrovascular Accident	2.5% 1/40 • Number of events 1 • 2 years
Vascular disorders Portal Vein Stenosis	5.0% 2/40 • Number of events 2 • 2 years
Vascular disorders Total Knee Anthroplasty	2.5% 1/40 • Number of events 1 • 2 years
Skin and subcutaneous tissue disorders Incisional Hernia Repair	2.5% 1/40 • Number of events 1 • 2 years
General disorders Lymphocele	2.5% 1/40 • Number of events 1 • 2 years
Renal and urinary disorders Moderate Allograft Rejection	2.5% 1/40 • Number of events 1 • 2 years
Infections and infestations Pneumonia	2.5% 1/40 • Number of events 1 • 2 years

Other adverse events

Measure

Tacrolimus and Mycophenolate Mofetil n=40 participants at risk All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days. tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis. mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.

Renal and urinary disorders Allograft rejection (mild)

7.5% 3/40 • Number of events 3 • 2 years

Additional Information

E. Steve Woodle, MD

University of Cincinnati

Phone: (513) 558-6001

Email: woodlees@uc.edu

Results disclosure agreements

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