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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CMVIG
Sponsored by
Tampa General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Renal, Transplant, PRA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LifeLink HealthCare Institute

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

CMVIG followed by PP

Arm Description

MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis

Outcomes

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
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
Monitor Patient Survival

Full Information

First Posted
November 4, 2008
Last Updated
June 22, 2015
Sponsor
Tampa General Hospital
Collaborators
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT00784979
Brief Title
Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation
Official Title
Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampa General Hospital
Collaborators
CSL Behring

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Immunological Testing Transplant Nephrectomy Pharmacologic Therapy Plasmapheresis 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Renal, Transplant, PRA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMVIG followed by PP
Arm Type
No Intervention
Arm Description
MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
Intervention Type
Drug
Intervention Name(s)
CMVIG
Other Intervention Name(s)
Cytomegalovirus Immune Globulin - Intravenous, Cytogam
Intervention Description
400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks
Primary Outcome Measure Information:
Title
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor
Description
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.
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
Monitor Graft Survival
Time Frame
5 years
Title
Monitor Patient Survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Leone, MD, PhD
Organizational Affiliation
Lifelink Healthcare Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
LifeLink HealthCare Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.tgmg.org
Description
Tampa General Medical Group

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

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