Improvement of Humoral Immune Response With Hemodialysis on BK-F Membrane: Correlation to Soluble CD40 Clearing

NCT01066559 | Completed

• 1 other identifier: CHUBX 2009/11
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of this study is to improve the humoral immune response efficiency of hemodialyzed patient by the use of PMMA membrane (BK-F) able to clear the soluble form of CD40 in a model of anti-HBV vaccination

Conditions

Chronic Renal Failure; Humoral Immune Alterations

Outcome Measures

Primary Outcomes (1)

• Percentage of patients who will respond to vaccination

  Week 40

Secondary Outcomes (3)

• Percentage and the level of anti-HBs antibodies

  at week 16, week 20, week 24 and week 40

• Correlation between the sCD40 levels and the response to HBV vaccination

  At week 12 and week 40

• Correlation between albuminemia, C-Reactive Protein, lymphocytes, parathyroid hormone, chronic immunosuppressive treatment or corticoid taking and vaccinal response.

  at week 12, week 24, and week 36

Study Arms (2)

High flux polymethylmetacrylate membrane

EXPERIMENTAL

Procedure: High flux polymethylmetacrylate membrane; Biological: Hepatitis B serological control; Biological: Seric sCD40 level

Polysulfone membranes

ACTIVE COMPARATOR

Procedure: Polysulfone membrane; Biological: Hepatitis B serological control; Biological: Seric sCD40 level

Interventions

High flux polymethylmetacrylate membrane PROCEDURE

Patients will be hemodialysed with high flux polymethylmetacrylate membranes

High flux polymethylmetacrylate membrane

Polysulfone membrane PROCEDURE

Patients be hemodialysed with polysulfone membranes

Polysulfone membranes

Hepatitis B serological control BIOLOGICAL

It will be assessed at week 16, week 20 and week 40

High flux polymethylmetacrylate membrane; Polysulfone membranes

Seric sCD40 level BIOLOGICAL

Ir will be measured at inclusion and week 12 by ELISA test according to the manufacturer instructions.

High flux polymethylmetacrylate membrane; Polysulfone membranes

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years, male or female
• Patient not immunized against hepatitis B despite complete well done anterior vaccination according to recommendations
• Hemodialyzed patients with hemodialysed sessions performed three times a week
• Patient able to give informed consent and affiliated to the medical insurance

You may not qualify if:

• Pregnant woman
• Patient never vaccinated against HBV
• Previous known hepatitis B even without anti HBs antibody (anti HBc antibody or HBs antigenemia positive)
• Active neoplasia or plasma cell dyscrasia
• VIH infection
• Known allergy to vaccine or to PMMA membrane
• Patient dialysed with PMMA membrane within three months before screening
• Necessity of acetate free biofiltration or hemodiafiltration as the technique of extrarenal epuration
• Vascular access problem with necessity of unipuncture for more than 30% of dialysis sessions.
• Patient under judicial protection

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (6)

CH Annonay

Annonay, France

Location

CH de la côte Basque

Bayonne, 64100, France

Location

CHU de Besançon

Besançon, 25000, France

Location

Saint-Augustin Clinic, Dialyze Unit

Bordeaux, 33000, France

Location

Pellegrin Hospital, Nephrology Unit

Bordeaux, 33076, France

Location

Larrey Hospital, Dialyze Unit

Toulouse, 31059, France

Location

Related Publications (1)

• de Precigout V, Germain C, Benard A, Lacraz A, Chauveau P, Deprele C, Seigneuric B, Pommereau A, Courivaud C, Douillet M, Taton B, Combe C, Contin-Bordes C. No Improvement of Hepatitis B Vaccination Response in Patients Dialysed with a Polymethylmethacrylate Membrane Compared to High-Flux Polysulfone: Results of the HEPADIAL Study. Blood Purif. 2020;49(3):265-271. doi: 10.1159/000504035. Epub 2019 Nov 13.

  PMID: 31722332 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Valérie de PRECIGOUT, MD

  University Hospital, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Pierre BORIES, MD

  University Hospital, Toulouse, France

  PRINCIPAL INVESTIGATOR

• Michel RINCE, MD

  University Hospital, Limoges, France

  PRINCIPAL INVESTIGATOR

• Caroline DELCLAUX, MD

  Hospital, Libourne, France

  PRINCIPAL INVESTIGATOR

• Antoine POMMEREAU, MD

  Clinic Saint-Augustin, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Benjamin DEROURE, MD

  Clinic Delay, Bayonne, France

  PRINCIPAL INVESTIGATOR

• Hervé BONAREK, MD

  Hospital, Saintes, France

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital, Bordeaux, France

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

FR (6)