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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00784979
Recruitment Status : Completed
First Posted : November 5, 2008
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Tampa General Hospital

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: CMVIG Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation
Study Start Date : January 2002
Actual Primary Completion Date : December 2010
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: CMVIG followed by PP
MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
 Drug: CMVIG
400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
Other Names:
  • Cytomegalovirus Immune Globulin - Intravenous
  • Cytogam


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Monitor Graft Survival [ Time Frame: 5 years ]
  2. Monitor Patient Survival [ Time Frame: 5 years ]

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784979


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

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Responsible Party: Tampa General Hospital
ClinicalTrials.gov Identifier: NCT00784979    
Other Study ID Numbers: IIS_100109
First Posted: November 5, 2008    Key Record Dates
Results First Posted: June 29, 2015
Last Update Posted: June 29, 2015
Last Verified: June 2015
Keywords provided by Tampa General Hospital:
Renal
Transplant
PRA
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs