Effects of High Cut-off (HCO) Hemodialysis on Central Memory CD4+ T and Treg Cells in Patients With End-stage Kidney Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Centre Hospitalier du Centre du Valais.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Research Unit CHCVs Hôpital de Sion Switzerland
Immunology ICHV Sion Switzerland
Immunology CHUV University Hospital Lausanne Switzerland
Nephrology CHUV University Hospital Lausanne Switzerland
Information provided by:
Centre Hospitalier du Centre du Valais
ClinicalTrials.gov Identifier:
NCT01103076
First received: April 13, 2010
Last updated: July 6, 2011
Last verified: March 2010
  Purpose

In this study, the investigators will evaluate whether CD4+ TCM producing effector cytokines can be distinguished on the basis of their expression of the IL-7 receptor alpha-chain (CD127). Using CD154 production as a marker of Ag-specific CD4+ T cells, the investigators will also test the hypothesis that the phenotype and function of TCM are influenced by the type of Ag they recognize. TCM specific for two cleared protein Ag, tetanus toxoïd (TT) and hepatitis B surface (HBs), inducing an early stage of CD4+ T cell differentiation will be compared to TCM specific for cytomegalovirus (CMV), a persistent virus inducing an advanced stage of CD4+ T cell differentiation.

The primary endpoint is to demonstrate in uremic patients who will begin chronic HD and in patients already chronically hemodialyzed any improvement in CD4+ T cell function ex vivo and in vitro. These analyzes will focus on memory T-cell subsets (i.e. Th17 and Tregs population) using HCO membranes or polyamide dialyzers.

The secondary endpoint is a clinical one, namely, to show any improvement in T cell response to HB and TT vaccination (blood antibody titers).


Condition Intervention Phase
End-stage Kidney Disease
CD4 T Cells
Central Memory T Cells
Regulatory T Cells
Uremic Toxins
Device: Polyamide HD membrane
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of High Cut-off Hemodialysis on Central Memory CD4+ T Cells and Regulatory T Cells in Patients With End-stage Kidney Disease

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier du Centre du Valais:

Primary Outcome Measures:
  • HCO 1100 membrane effect on T CM and Tregs in patients with ESKD chronically hemodialzed [ Time Frame: 12 HD sessions ] [ Designated as safety issue: Yes ]
    The primary endpoint is to demonstrate in uremic patients who will begin chronic HD and in patients already chronically hemodilyzed any improvement in CD4+ T cell function ex vivo and in vitro. These analyzes will focus on memory T-cell subsets (i.e. Th17 and Tregs population) using HCO membranes or polyamide dialyzers.


Secondary Outcome Measures:
  • Immunogenicity of the HB-AS04 vaccine in patients dialyzed with HCO 1100 or polyamide membranes [ Time Frame: 12 months study ] [ Designated as safety issue: Yes ]
    The secondary endpoint is a clinical one, namely, to show any improvement in T cell response to HB and TT vaccination (blood antibody titers).


Estimated Enrollment: 20
Study Start Date: April 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polyamide 210 H
Chronic HD patients will be treated in random order with either polyamide or HCO membranes (Polyflux 210 H or HCO 1100) for one month (12 HD sessions) before the crossover.
Device: Polyamide HD membrane
Single use polyamide membrane
Experimental: HCO 1100
Chronic HD patients will be treated in random order with either polyamide or HCO membranes (Polyflux 210 H or HCO 1100) for one month (12 HD sessions) before the crossover.
Device: Polyamide HD membrane
Single use polyamide membrane

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ESKD (CKD stage 5D according to K/DOQI guidelines) regularly treated by bicarbonate HD 3 times a week for at least 4 h at a blood flow rate of 300 ml/min will be included

Exclusion Criteria:

  • Only non-smokers will be enrolled in the study
  • Patients with recent (< 3 mo) major trauma, surgery, myocardial infarction, coronary revascularization (coronary angioplasty or bypass surgery), or stroke will be excluded from the study
  • Diabetes mellitus
  • The presence of an acute or chronic inflammatory process, infection
  • Malnutrition (determined by Subjective Global Nutritional Assessment)
  • The use of immunosuppressive drugs or evidence of malignancy
  • Pregnant women, women who are breast feeding or are of child-bearing potential and not using adequate contraceptive precautions are excluded
  • A pregnancy test will be performed in female patients before the inclusion
  • Except for aspirin and statin, those patients taking anti-inflammatory medications in the prior 4 weeks will be excluded.
  • All patients have to be negative for circulating hepatitis B antigen, hepatitis C antibody (Ab) and HIV
  • They will have no active liver disease
  • No patient will be nephrectomized
  • Arterial blood pH will be between 7.38 and 7.42
  • No patient will receive a blood transfusion in the 6 mo before the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01103076

Contacts
Contact: Pascal Meier, MD +41276034000 ext 8647 pascal.meier@hopitalvs.ch

Locations
Switzerland
Hôpital de Sion CHCVs Recruiting
Sion, Valais, Switzerland, 1951
Contact: Pascal Meier, MD    +41276034000 ext 8647    pascal.meier@rsv-gnw.ch   
Principal Investigator: Pascal Meier, MD         
Sponsors and Collaborators
Centre Hospitalier du Centre du Valais
Research Unit CHCVs Hôpital de Sion Switzerland
Immunology ICHV Sion Switzerland
Immunology CHUV University Hospital Lausanne Switzerland
Nephrology CHUV University Hospital Lausanne Switzerland
Investigators
Principal Investigator: Pascal Meier, MD Nephrology service CHCVs Hôpital de Sion/Switzerland
  More Information

Additional Information:
Publications:
Responsible Party: Pascal Meier MD, CHCVs Hôpital de Sion
ClinicalTrials.gov Identifier: NCT01103076     History of Changes
Other Study ID Numbers: HighCO Hemo study, HCO study
Study First Received: April 13, 2010
Last Updated: July 6, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by Centre Hospitalier du Centre du Valais:
Immune dysfunction
Hemodialysis
HBV
Vaccination
Immune response

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 14, 2014