Trial Outcomes & Findings for Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation (NCT NCT00206076)

NCT ID: NCT00206076

Last Updated: 2013-08-02

Results Overview

assessed by liver biopsy using Banff International Consensus Schema

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2013-08-02

Participant Flow

Participants were current patients from 3 outpatient transplant offices and recruited between July 2006 and May 2008.

Participants were screened over a 2 week period. Three participants withdrew consent after signing the consent form. One participant failed screening (didn't attain threshold MPA level). These subjects were excluded from the trial before assignment to groups.

Participant milestones

Measure	MMF, CNI Discontinued Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
Overall Study STARTED	9	10
Overall Study COMPLETED	6	9
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	MMF, CNI Discontinued Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
Overall Study Physician Decision	2	0
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation

Baseline characteristics by cohort

Measure	MMF, CNI Discontinued n=9 Participants Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased n=10 Participants Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage	Total n=19 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	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	56.11 years STANDARD_DEVIATION 8.46 • n=5 Participants	54.6 years STANDARD_DEVIATION 7.26 • n=7 Participants	55.32 years STANDARD_DEVIATION 7.67 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

assessed by liver biopsy using Banff International Consensus Schema

Outcome measures

Measure	MMF, CNI Discontinued n=6 Participants Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased n=9 Participants Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
Number of Biopsy Proven Rejections at 12 Months	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 months

Population: everyone enrolled who completed the study

Outcome measures

Measure	MMF, CNI Discontinued n=6 Participants Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased n=9 Participants Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
Patient and Graft Survival at 12 Months	6 participants	9 participants

SECONDARY outcome

Timeframe: 12 months

Population: everyone enrolled who completed the study

Outcome measures

Measure	MMF, CNI Discontinued n=6 Participants Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased n=9 Participants Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
Number of Participants With Adverse Events Including Infections at 12 Months	2 participants	1 participants

Adverse Events

MMF, CNI Discontinued

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

MMF; CNI Decreased

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	MMF, CNI Discontinued n=9 participants at risk Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased n=10 participants at risk Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
Gastrointestinal disorders Nausea	11.1% 1/9 • Number of events 1	0.00% 0/10
Gastrointestinal disorders Constipation alter with diarrhea	11.1% 1/9 • Number of events 1	0.00% 0/10
Gastrointestinal disorders diarrhea	11.1% 1/9 • Number of events 1	0.00% 0/10
Gastrointestinal disorders gastroenteritis	0.00% 0/9	10.0% 1/10 • Number of events 1
Blood and lymphatic system disorders change in white blood cell count	0.00% 0/9	10.0% 1/10 • Number of events 1

Other adverse events

Measure	MMF, CNI Discontinued n=9 participants at risk Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)	MMF; CNI Decreased n=10 participants at risk Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
Respiratory, thoracic and mediastinal disorders Cough	22.2% 2/9 • Number of events 3	20.0% 2/10 • Number of events 3
Respiratory, thoracic and mediastinal disorders Nasal congestion	11.1% 1/9 • Number of events 1	30.0% 3/10 • Number of events 4
Gastrointestinal disorders Diarrhea	66.7% 6/9 • Number of events 8	60.0% 6/10 • Number of events 6
Gastrointestinal disorders Nausea	22.2% 2/9 • Number of events 2	30.0% 3/10 • Number of events 4
Hepatobiliary disorders Increased liver enzymes	22.2% 2/9 • Number of events 3	10.0% 1/10 • Number of events 3

Additional Information

David Reich, MD

Drexel University College of Medicine

Phone: 215-762-7143

Email: David.Reich@DrexelMed.edu

Results disclosure agreements

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