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

Tampa General Hospital26 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Disease

Interventions

CMVIGDRUG

400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

LifeLink HealthCare Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor

The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.

Time frame: four weeks

Secondary Outcomes

Monitor Graft Survival

Time frame: 5 years

Monitor Patient Survival

Time frame: 5 years

Data from ClinicalTrials.gov

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