NCT01698736

Brief Summary

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2012

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

4 months

First QC Date

September 26, 2012

Last Update Submit

January 15, 2018

Conditions

Immunology

Keywords

ABO isoagglutininsABO incompatible transplantationimmunoadsorptionmembrane filtrationplasmapheresis

Outcome Measures

Primary Outcomes (1)

  • Percent reduction in flow cytometric ABO blood group specific IgM serum levels upon a single apheresis treatment

    Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours).

Secondary Outcomes (1)

  • Percent reduction in flow cytometric ABO blood group specific IgG serum levels upon a single apheresis treatment

    Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours).

Other Outcomes (4)

  • Effect on titers of ABO blood group specific IgG (indirect Coombs test)

    Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours).

  • Effect on titers of ABO blood group specific IgM (direct agglutination test)

    Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours).

  • Effect on concentrations of total serum IgG

    Blood samples will be taken within one hour before (baseline) and within one hour after each apheresis treatment (average apheresis duration 6 hours).

  • +1 more other outcomes

Study Arms (2)

Semiselective IA

ACTIVE COMPARATOR

Semiselective immunoadsorption (GAM peptide adsorber)

Device: Semiselective IA

Semiselective IA + membrane filtration

EXPERIMENTAL

Semiselective immunoadsorption (GAM peptide adsorber) in combination with membrane filtration

Device: Membrane filtrationDevice: Semiselective IA

Interventions

Membrane filtrationDEVICE

Membrane filtration (Polysulfone)

Semiselective IA + membrane filtration
Semiselective IADEVICE

Semiselective immunoadsorption (GAM peptide adsorber)

Semiselective IASemiselective IA + membrane filtration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age ≤ 18a
  • Blood group AB (no isoagglutinins)
  • No signed consent
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Wahrmann M, Schiemann M, Marinova L, Kormoczi GF, Derfler K, Fehr T, Stussi G, Bohmig GA. Anti-A/B antibody depletion by semiselective versus ABO blood group-specific immunoadsorption. Nephrol Dial Transplant. 2012 May;27(5):2122-9. doi: 10.1093/ndt/gfr610. Epub 2011 Nov 15.

    PMID: 22086972BACKGROUND

Study Officials

  • Georg Böhmig, MD

    Department of Nephrology, Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 26, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

AU(1)