Trial Outcomes & Findings for Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant (NCT NCT00446251)

Results Overview

the number of subjects who experience a decrease in their Panel of Reactive Antibodies (PRA) at 6 months and 12 months post Rituximab infusion

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Month 6 from start of study

Results posted on

2010-04-06

Participant Flow

Subjects were recruited from the parent study: "Highly Sensitized Patients: effects of mycophenolate mofetil (MMF) on anti-human lymphocyte antibody levels in patients awaiting renal transplant" study" at 8 months if the subject had not experienced a 10% or greater reduction in Panel of Reactive Anti-bodies(PRA.

Single arm study: all subjects received 2 Rituximab infusions of 1,000 mg. Subjects were kept at their highest tolerated dose of mycophenolate mofetil(MMF)from parent study.

Participant milestones

Participant milestones
Measure	Rituximab Infusion and Mycophenolate Mofetil Group Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
Overall Study STARTED	14
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab Infusion and Mycophenolate Mofetil Group Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
Overall Study On-study Transplants	2
Overall Study Rituximab Infusion Reaction	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab Infusion and Mycophenolate Mofetil Group n=14 Participants Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	41.3 years STANDARD_DEVIATION 8.81 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6 from start of study

Population: 12 subjects received the full dose of Rituximab AND continued to month 6 post infusion.

the number of subjects who experience a decrease in their Panel of Reactive Antibodies (PRA) at 6 months and 12 months post Rituximab infusion

Outcome measures

Outcome measures
Measure	Rituximab Infusion and Mycophenolate Mofetil Group n=12 Participants Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
The Number of Subjects Who Experience a Decrease in Their Panel of Reactive Antibodies (PRA) at 6 Months Post Rituximab Infusion.	6 Participants

SECONDARY outcome

Timeframe: Month 12 from start of study

Outcome measures

Outcome measures
Measure	Rituximab Infusion and Mycophenolate Mofetil Group n=12 Participants Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
The Number of Subjects Who Experience a Change From Baseline in Their Panel of Reactive Antibody (PRA) Titers at 12 Months Post Rituximab Infusion.	6 Participants

SECONDARY outcome

Timeframe: Month 12 from start of study

Population: As per protocol each subject was entered with intention to treat.

Outcome measures

Outcome measures
Measure	Rituximab Infusion and Mycophenolate Mofetil Group n=12 Participants Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
The Number of Subjects With a Negative Crossmatch at the Time of Transplant.	0 Participants

Adverse Events

Rituximab Infusion and Mycophenolate Mofetil Group

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab Infusion and Mycophenolate Mofetil Group n=14 participants at risk Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
Cardiac disorders Chest pain	7.1% 1/14 • Number of events 1

Other adverse events

Other adverse events
Measure	Rituximab Infusion and Mycophenolate Mofetil Group n=14 participants at risk Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
Immune system disorders Leukopenia	7.1% 1/14 • Number of events 1
Immune system disorders Infusion reaction	14.3% 2/14 • Number of events 2
Gastrointestinal disorders Pancreatitis	7.1% 1/14 • Number of events 1

Additional Information

Dr. Connie L. Davis

University of Washington

Phone: 206-598-6079

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60