Trial Outcomes & Findings for Efficacy of Belatacept in Reducing DSA (NCT NCT02078193)

NCT ID: NCT02078193

Last Updated: 2017-08-01

Results Overview

DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: one year
• Results posted on: 2017-08-01

Participant Flow

Participant milestones

Measure	Belatacept All patients enrolled will be converted to Belatacept from prograf.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Belatacept in Reducing DSA

Baseline characteristics by cohort

Measure	Belatacept n=3 Participants All patients enrolled will be converted to Belatacept from prograf.
Age, Continuous	58.3 years STANDARD_DEVIATION 5.51 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	1 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	1 Participants n=5 Participants
Race (NIH/OMB) White	2 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
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: one year

DSA levels will be measured using microbeads coated with Class I or Class II human leukocyte antigens (HLA) and read using a Luminex flow cytometer. Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept.

Outcome measures

Measure	Belatacept n=3 Participants Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept Belatacept: Patients will be converted from their MMF to Belatacept
Change of Donor Specific Antibodies (DSA)	35.7 percent change in DSAs Standard Deviation 45.8

SECONDARY outcome

Timeframe: one year

Population: Number of participants with infections

Incidence of infections

Outcome measures

Measure	Belatacept n=3 Participants Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept Belatacept: Patients will be converted from their MMF to Belatacept
Safety	2 Participant

OTHER_PRE_SPECIFIED outcome

Timeframe: One year

Incidence of chronic kidney rejection

Outcome measures

Measure	Belatacept n=3 Participants Participants will be converted from their current Mycophenolate Mofetil (MMF) to once a month infusions of Belatacept Belatacept: Patients will be converted from their MMF to Belatacept
Number of Participants With Chronic Kidney Rejection	0 participants

Adverse Events

Belatacept

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Belatacept n=3 participants at risk All patients enrolled will be converted to Belatacept from prograf.
Respiratory, thoracic and mediastinal disorders COPD exacerbation	66.7% 2/3 • Number of events 2

Additional Information

Austin Rice

East Carolina University, Division of Nephrology

Phone: 252-744-1904

Email: riceau15@ecu.edu

Results disclosure agreements

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