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

Completed · Phase 4

Conditions studied: End Stage Renal Disease

In brief

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

Key facts

Study ID

NCT00784979

Run by

Tampa General Hospital

People needed

26

Starts

2002-01-01

Expected to finish

2012-04-01

Last updated by the study team

2015-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• LifeLink HealthCare Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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