Trial Outcomes & Findings for Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation (NCT NCT00784979)

Results Overview

The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

four weeks

Results posted on

2015-06-29

Participant Flow

Participant milestones

Participant milestones
Measure	CMVIG Followed by PP MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
Overall Study STARTED	26
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	CMVIG Followed by PP MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
Overall Study incomplete data	6

Baseline Characteristics

Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Highly Sensitized Patients n=26 Participants Highly-sensitized patients were defined as those having PRA \>/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
Age, Continuous	42 years STANDARD_DEVIATION 10.6 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	13 Participants n=99 Participants
Percent of subjects with PRA >/= 20% in last 12 months	76 percent of subjects with elevated PRA n=99 Participants

PRIMARY outcome

Timeframe: four weeks

The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.

Outcome measures

Outcome measures
Measure	Highly Sensitized Patients n=20 Participants Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor	40 percent of subjects becoming compatible

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years

Outcome measures

Outcome data not reported

Adverse Events

Highly Sensitized Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Leone

Tampa General Hospital

Phone: 813-844-5666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place