Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tampa General Hospital
• Collaborator: CSL Behring
• Treatments: Antibodies; Immunoglobulins

Criteria

Inclusion Criteria:

• Renal transplant recipients with a potential living donor who is incompatible (T-&/or B-cell locus) due to recipient high PRA or MHC antibodies

• PRA greater than or equal to 20% within last twelve months

• Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal Transplant Committee

Exclusion Criteria:

• Patients with known allergy to CytoGam(R), Cellcept, Rapamycin

• Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process

• ABO incompatibility

• Patients not capable of following through the treatment for various reasons as determined by treating physicians

• Any potential recipient who is pregnant or becomes pregnant

• Exclusion for Plasmapheresis: known allergy to ethylene oxide or natural rubber latex.

• Exclusion for Plasmapheresis: Intake of ACE-inhibitor or Angtiotensiin-receptor blockers in the last 24 hours prior to plasma exchange