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

End Stage Renal Disease Clinical Trial

Official title:

Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784979
• Other study ID #: IIS_100109
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2008
• Last updated: June 22, 2015
• Start date: January 2002
• Est. completion date: April 2012

Study information

• Verified date: June 2015
• Source: Tampa General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• CMVIG
400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks

Locations

Country	Name	City	State
United States	LifeLink HealthCare Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Tampa General Hospital	CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	four weeks	No
Secondary	Monitor Graft Survival		5 years	No
Secondary	Monitor Patient Survival		5 years	No

External Links

•   Tampa General Medical Group