ABO Blood Group Antibody Elimination by a Combination of Semiselective Immunoadsorption Therapy and Membrane Filtration

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
Farsad Eskandary, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01698736
First received: September 26, 2012
Last updated: February 28, 2013
Last verified: February 2013
  Purpose
  • Recipient desensitization protocols were shown to enable successful living donor kidney transplantation across major ABO blood group barriers. For extracorporeal depletion of circulating ABO antibodies plasmapheresis or ABO blood group specific immunoadsorption (IA) are most commonly used.
  • The efficiency of semiselective non-antigen specific IA in ABO-incompatible transplantation is currently not well established. One potential drawback of semiselective adsorbers could be an incomplete elimination of IgM.
  • This randomized controlled crossover trial was designed to clarify whether membrane filtration, as an adjunct to semiselective IA, can substantially enhance elimination of IgM.

Condition Intervention
Decreased Immunologic Activity [PE]
Device: Membrane filtration
Device: Semiselective IA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ABO Blood Group Antibody Elimination by a Combination of Semiselective Immunoadsorption Therapy and Membrane Filtration

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Percent reduction in flow cytometric ABO blood group specific IgM serum levels upon a single apheresis treatment [ Time Frame: Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent reduction in flow cytometric ABO blood group specific IgG serum levels upon a single apheresis treatment [ Time Frame: Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours). ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Effect on titers of ABO blood group specific IgG (indirect Coombs test) [ Time Frame: Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours). ] [ Designated as safety issue: No ]
  • Effect on titers of ABO blood group specific IgM (direct agglutination test) [ Time Frame: Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours). ] [ Designated as safety issue: No ]
  • Effect on concentrations of total serum IgG [ Time Frame: Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours). ] [ Designated as safety issue: No ]
  • Effect on concentrations of total serum IgM [ Time Frame: Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours). ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: October 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Semiselective IA
Semiselective immunoadsorption (GAM peptide adsorber)
Device: Semiselective IA
Semiselective immunoadsorption (GAM peptide adsorber)
Experimental: Semiselective IA + membrane filtration
Semiselective immunoadsorption (GAM peptide adsorber) in combination with membrane filtration
Device: Membrane filtration
Membrane filtration (Polysulfone)
Device: Semiselective IA
Semiselective immunoadsorption (GAM peptide adsorber)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18a
  • Blood group A, B or O
  • Regular IA treatment for a disease not related to transplantation
  • Use of semiselective IA with GAM peptide adsorbers
  • IA treatment interval ≥ 7 days

Exclusion Criteria:

  • Age ≤ 18a
  • Blood group AB (no isoagglutinins)
  • No signed consent
  • Pregnancy or breast feeding women (exclusion of pregnancy with pregnancy test)
  • Severe disease precluding immunoglobulin elimination by IA (e.g. severe infection)
  • Elevated risk of bleeding or coagulation disorders that make systemic anticoagulation with heparin impossible
  • Hypersensitivity to heparin or HIT
  • Hypersensitivity to polysulfone
  • Participation in other clinical study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01698736

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Fresenius Medical Care Deutschland GmbH
Investigators
Principal Investigator: Georg Böhmig, MD Department of Nephrology, Medical University of Vienna
  More Information

Publications:
Responsible Party: Farsad Eskandary, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01698736     History of Changes
Other Study ID Numbers: EK 1540/2012
Study First Received: September 26, 2012
Last Updated: February 28, 2013
Health Authority: Austria: Austrian Medicines and Medical Devices Agency
Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
ABO isoagglutinins
ABO incompatible transplantation
immunoadsorption
membrane filtration
plasmapheresis

ClinicalTrials.gov processed this record on July 29, 2014