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

NCT00784979 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2015-06-29

Study results available
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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

Conditions

Interventions

DRUG

CMVIG

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

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Tampa General Hospital

    lead OTHER

Principal Investigators

  • John Leone, MD, PhD · Lifelink Healthcare Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2010-12-31
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00784979 on ClinicalTrials.gov