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

This study has been completed.
CSL Behring
Information provided by (Responsible Party):
Tampa General Hospital Identifier:
First received: November 4, 2008
Last updated: June 22, 2015
Last verified: June 2015

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

Condition Intervention Phase
End Stage Renal Disease
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation

Resource links provided by NLM:

Further study details as provided by Tampa General Hospital:

Primary Outcome Measures:
  • The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor [ Time Frame: four weeks ]
    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.

Secondary Outcome Measures:
  • Monitor Graft Survival [ Time Frame: 5 years ]
  • Monitor Patient Survival [ Time Frame: 5 years ]

Enrollment: 26
Study Start Date: January 2002
Study Completion Date: April 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CMVIG followed by PP
MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
Other Names:
  • Cytomegalovirus Immune Globulin - Intravenous
  • Cytogam

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00784979

United States, Florida
LifeLink HealthCare Institute
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Tampa General Hospital
CSL Behring
Principal Investigator: John Leone, MD, PhD Lifelink Healthcare Institute
  More Information

Additional Information:
Responsible Party: Tampa General Hospital Identifier: NCT00784979     History of Changes
Other Study ID Numbers: IIS_100109
Study First Received: November 4, 2008
Results First Received: April 28, 2014
Last Updated: June 22, 2015

Keywords provided by Tampa General Hospital:

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017