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Completed

NCT Number: NCT00784979

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

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

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Key information

Conditions

End Stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LifeLink HealthCare Institute

Tampa, Florida, 33606, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMVIG

Drug

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

Other names: Cytomegalovirus Immune Globulin - Intravenous, Cytogam

Primary outcomes

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

    Time frame: 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 outcomes

  1. Monitor Graft Survival

    Time frame: 5 years

  2. Monitor Patient Survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Tampa General Hospital

Other

Collaborators

  • CSL Behring

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2010
Study completion
2012
First posted
Nov 5, 2008
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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