Trial Outcomes & Findings for The Effect of Rituximab on the Development of Anti-Donor Antibodies (NCT NCT00695097)
NCT ID: NCT00695097
Last Updated: 2014-03-26
Results Overview
Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.
COMPLETED
NA
18 participants
1 year
2014-03-26
Participant Flow
Consecutive patients with biopsy-proven ACR were recruited in the kidney transplant Clinic at UCSF and were randomized to either the Rituximab or the control group.
18 patients were consented to participate. 3 patients failed eligibility screening prior to treatment assignment. 15 were eligible, 10 were in the Rituximab group and 5 in the no-Rituximab group.
Participant milestones
| Measure |
Rituximab Group
Rituximab Group: Rituximab dose is 1000 mg given as an IV infusion every 2 weeks (day 1 and 15) and followed monthly for 1 year.
|
Control Group
No Rituximab; Standard maintenance immunosuppressive regimen only and being followed monthly for 1 year.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
5
|
|
Overall Study
COMPLETED
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Rituximab on the Development of Anti-Donor Antibodies
Baseline characteristics by cohort
| Measure |
Rituximab Group
n=10 Participants
Rituximab Group: The Rituximab dose is 1000mg (1gm) given as an IV infusion every two weeks for 2 doses (days 1 and 15) and followed monthly for 1 year.
|
Control Group
n=5 Participants
No Rituximab; Standard maintenance immunosuppressive regimen only followed up monthly for 1 year.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
5 participants
n=107 Participants
|
15 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: 5 Rituximab participants and 4 Control participants provided both baseline and follow-up biopsies for analysis. 6 participants withdrew their consent.
Follow-up biopsy was done 3-6 months after study treatment. Study follow-up monthly for 1 year.
Outcome measures
| Measure |
Rituximab Group
n=5 Participants
Rituximab infusion day 1 and 15
|
Control Group
n=4 Participants
No Rituximab infusion
|
|---|---|---|
|
Change in Biopsy Cell Densities From Baseline to Follow-up
CD20
|
-129.4 cells/mm^3
Standard Deviation 0.054
|
30.4 cells/mm^3
Standard Deviation 0.062
|
|
Change in Biopsy Cell Densities From Baseline to Follow-up
CD3
|
-164 cells/mm^3
Standard Deviation 0.25
|
-122.5 cells/mm^3
Standard Deviation 0.46
|
Adverse Events
Rituximab Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Flavio Vincenti
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place