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

Tampa General Hospital (TGH)

Status and phase: Completed; Phase 4

Conditions: End Stage Renal Disease

Treatments: Drug: CMVIG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00784979

IIS_100109

Details and patient eligibility

About

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

Full description

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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

CMVIG followed by PP

No Intervention group

Description:

MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis

Treatment:

Drug: CMVIG