NCT00784979

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Tampa General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	CMVIG	400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks

Timeline

• Start date: 2002-01-01
• Primary completion: 2010-12-01
• Completion: 2012-04-01
• First posted: 2008-11-05
• Last updated: 2015-06-29
• Results posted: 2015-06-29

Locations

1 site across 1 country: United States