Phase 4 N=26 Treatment

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

End Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT00784979 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2015

Primary outcome: Primary: The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor — 40 percent of subjects becoming compatible

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: CMVIG (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tampa General Hospital
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor	40	—
SECONDARY Monitor Graft Survival	—	—
SECONDARY Monitor Patient Survival	—	—

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00784979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.