Conditions: End Stage Renal Disease
Keywords: Renal Transplant PRA
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: no

Brief summary:
The purpose of this study is to offer Panel Reactive Antibodies \[PRA\] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:

1. Immunological Testing
2. Transplant Nephrectomy
3. Pharmacologic Therapy
4. Plasmapheresis
5. Transplant

Detailed description:
Patients with high level of preformed antibodies (panel reactive antibodies \[PRA\]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.

Arms:
arm 1: MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis

Interventions: intervention 1: CMVIG
Intervention descriptions: intervention 1: 400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks

Protocol document: