Trial Outcomes & Findings for Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients (NCT NCT00586716)
NCT ID: NCT00586716
Last Updated: 2017-01-09
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
1 year
Results posted on
2017-01-09
Participant Flow
Participant milestones
| Measure |
Group 1 Intravenous Immune Globulin no Living Donor
Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments
|
Group 2 Intravenous Immune Globulin With Living Donor
Patients who have living donors with positive crossmatch results.
intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
8
|
|
Overall Study
COMPLETED
|
14
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
IVIG no Living Donor
n=14 Participants
Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
|
IVIG With Living Donor
n=8 Participants
Intravenous immune globulin for patients who have living donors with positive crossmatch results.
|
Total
n=22 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
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown
|
14 participants
n=5 Participants
|
8 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Study was terminated and no data for the outcome was collected/analyzed because it could not be located.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1yearPopulation: Study was terminated and no data for the outcome was collected/analyzed because it could not be located.
Outcome measures
Outcome data not reported
Adverse Events
Group 1 Intravenous Immune Globulin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Intravenous Immune Globulin
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place