Expired Study
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Tampa, Florida 33606


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

Study summary:

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.


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



Primary Contact:

Principal Investigator
John Leone, MD, PhD
Lifelink Healthcare Institute

Backup Contact:


Location Contact:

Tampa, Florida 33606
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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