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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Dr. John Leone, Tampa General Hospital
ClinicalTrials.gov Identifier:
NCT00784979
First received: November 4, 2008
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Kidney Transplantation
End Stage Renal Disease
 Drug: Cytogam
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Tampa General Hospital:

Primary Outcome Measures:
  • Determine number of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor [ Time Frame: four weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monitor graft survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Monitor patient survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2002
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Cytogam
    400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
    Other Names:
    • Cytomegalovirus Immune Globulin - Intravenous
    • CMVIG
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784979

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

Additional Information:
Tampa General Medical Group  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. John Leone, MD, Tampa General Hospital
ClinicalTrials.gov Identifier: NCT00784979     History of Changes
Other Study ID Numbers: IIS_100109
Study First Received: November 4, 2008
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Tampa General Hospital:
Renal
Transplant
PRA

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Immunoglobulins
 Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013