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

Study Overview
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Brief Summary
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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: Immunological Testing Transplant Nephrectomy Pharmacologic Therapy Plasmapheresis Transplant

Detailed Description
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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.

Official Title
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Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Drug: CMVIG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: CMVIG followed by PP<br>MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis | Drug: CMVIG<br>* 400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks<br>* Other names: Cytogam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitor Graft Survival |  | 5 years | 
| Monitor Patient Survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal, Transplant, PRA