Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Tampa, Florida 33606


Purpose:

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.


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


NCT ID:

NCT00784979


Primary Contact:

Principal Investigator
John Leone, MD, PhD
Lifelink Healthcare Institute


Backup Contact:

N/A


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

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.