Trial Outcomes & Findings for Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates (NCT NCT00986947)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

4 months

Results posted on

2017-06-01

20 participants were enrolled.

Participant milestones
Measure	IvIg With Rituximab IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses. If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).
Overall Study STARTED	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	20

Withdrawal data not reported

Desensitization of Highly Sensitized Deceased Donor Renal Transplantation Candidates

Baseline characteristics by cohort
Measure	IvIg With Rituximab n=20 Participants IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses. If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA).
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Region of Enrollment United States	20 participants n=99 Participants

Timeframe: 4 months

Population: Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.

Outcome data not reported

Timeframe: 4 months

Population: Data was not collected for this outcome measure. The study was terminated prematurely due to the P.I. leaving the institution.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Johns Hopkins University School of Medicine

Phone: 410-550-6484