End Stage Renal Disease
Conditions
Keywords
transplant, desensitization, kidney transplant
Brief summary
This is a study of patients who have a high risk of kidney rejection before kidney transplant. The hypothesis is that treatment with a medication called rituximab will make it possible for them to receive a kidney transplant from a donor who previously did not present a good match.
Interventions
DRUGrituximab
Rituximab 375mg/m2 IV weekly times 4 weeks
Sponsors
Genentech, Inc.
University of Wisconsin, Madison
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active status on a kidney transplant waiting list with positive cross match against a living donor
Exclusion criteria
* Receipt of a live vaccine within 4 weeks prior to randomization * Previous Treatment with Rituximab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Conversion of a positive donor specific cross-match to a living donor to a negative cross-match thereby allowing successful transplantation. | assess 4 weeks after Rituximab treatment completed |
| Transplant success or failure following the desensitization protocol. | ongoing assessment for 2 years after transplant |
Secondary
| Measure | Time frame |
|---|---|
| Decrease in incidence of humoral rejection to less than 50% at 1 year. | assess 1 year after transplant |
Countries
United States
Outcome results
None listed