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

Phase 4

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: CMVIG

• Registration Number: NCT00784979
• Lead Sponsor: Tampa General Hospital

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

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 Timeline

• Study Start: 2002-01
• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Primary Completion: 2010-12
• Study Completion: 2012-04
• Results First Submitted: 2014-04-28
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Results First Posted: 2015-06-29
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CMVIG followed by PP	CMVIG	MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis

Primary Outcome Measures

Name	Time	Method
The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor	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

Name	Time	Method
Monitor Graft Survival	5 years
Monitor Patient Survival	5 years

Trial Locations

Locations (1)

LifeLink HealthCare Institute; 🇺🇸 Tampa, Florida, United States