Evaluation of 2 Techniques of Apheresis to Desensitize ABO Incompatible Kidney Transplant Candidates

NCT03477656 | Completed

• 1 other identifier: RC31/16/8767
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney transplantation is the treatment of choice for end-stage renal disease. ABO incompatible (ABOi) living donor kidney transplantation is one of the best ways to expand the donors' pool. However, breaking the ABO barrier is possible only with a preconditioning regimen that includes 1) an immunosuppressive strategy using a B-cell depleting agent (rituximab), an induction therapy with polyclonal antibodies, and a maintenance triple immunosuppressive therapy based on calcineurin inhibitors, and 2) a desensitization protocol aiming to decrease the titer of isoagglutinins. For this purpose, several techniques of apheresis are available. To date, two main techniques used in clinical setting are the Double-Filtration PlasmaPheresis (DFPP) and the Antigen-Specific Immunoadsorption (SIA). DFPP permits the depletion of the selective plasma fraction containing Immunoglobulins, while limiting the need for plasma substitution. SIA enables to remove ABO antibodies without a major loss in essential plasma components. To date, no randomized study comparing DFPP and SIA exist. SIA is less often used because of its high cost. However, in order to reduce the number of SIA sessions and consequently its cost, large plasma volume sessions of SIA are performed. ABOi is dramatically more expensive than ABO compatible kidney transplantation. A large part of the difference in the cost is related to the apheresis technique. Herein, the investigator proposes to describe the efficacy, the safety, and the cost of DFPP and SIA to desensitize ABO incompatible kidney transplant candidates.

Conditions

Kidney Transplantation

Keywords

ABO incompatible kidney transplantation; Desensitization; Double Filtration PlasmaPherisis (DFPP); Specific immunoadsorption; Living donor kidney transplantation

Outcome Measures

Primary Outcomes (1)

• Success rate

  % of subjects with the targeted isoagglutinin titer (≤1/4) before transplantation with less than 5 DFPP sessions (for the DFPP arm) or 2 large plasma volume specific immunoadsorption sessions (for the specific immunoadsorption arm)

  the day of transplantation

Secondary Outcomes (34)

• Differential cost-efficacy ratio of support for patients receiving a live donor kidney transplant Incompatible ABO and benefiting from a desensitization procedure

  7 months

• Surgical complication rate during the desensitization sessions

  From the first desensitization session to the last one, assessed up to 10 days

• Surgical complication rate during the transplantation surgery

  During the transplantation surgery

• Thrombotic complication rate during the desensitization sessions

  From the first desensitization session to the last one, assessed up to 10 days

• Thrombotic complication rate 1 week after transplantation surgery

  1 week after transplantation surgery

Study Arms (2)

Large volume specific immunoadsorption

EXPERIMENTAL

1 to 2 sessions of large volume specific immunoadsorption according to the initial isoagglutinin titer.

Procedure: Large volume specific immunoadsorption

Double Filtration Plasmapheresis

EXPERIMENTAL

1 to 5 sessions of double filtration plasmapheresis according to the initial isoagglutinin titer.

Procedure: Double Filtration Plasmapheresis

Interventions

Large volume specific immunoadsorption PROCEDURE

1 to 2 sessions of large volume specific immunoadsorption using GLYCOSORB®-ABO column

Large volume specific immunoadsorption

Double Filtration Plasmapheresis PROCEDURE

1 to 5 sessions of double filtration plasmapheresis

Double Filtration Plasmapheresis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient eligible for living donor ABO incompatible kidney transplantation
• Presenting an IsoAgglutinin immunoglobulin G titer (anti-A-B) between 1/8 and 1/128, before desensitization
• Patient older than 18 years
• Women of childbearing age must have a pregnancy test before starting the study and undergoing study. They must take an effective and acceptable method of contraception before starting the study and throughout the study period. Sexually active men should use a condom throughout the course of the study
• Patient able to sign an informed consent form
• Patient affiliated with a social security scheme

You may not qualify if:

• Presence of anti-HLA (Human Leucocyte Antigens) allo-antibodies
• Patient with comorbidities that prevent desensitization protocols
• Women who are pregnant, or who may become pregnant or breastfeeding women
• History of hypersensitivity related to a component of the apheresis membrane
• Subjects under legal protection

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse (Hospital Rangueil)

Toulouse, 31059, France

Location

MeSH Terms

Interventions

Plasmapheresis

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Arnaud DEL BELLO, MD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 26, 2018
• Study Start: May 2, 2018
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)