Status:
COMPLETED
Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation
Lead Sponsor:
Tampa General Hospital
Collaborating Sponsors:
CSL Behring
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 don...
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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00784979
Start Date
January 1 2002
End Date
April 1 2012
Last Update
June 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
LifeLink HealthCare Institute
Tampa, Florida, United States, 33606