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

NCT01103076 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2011-07-07

No results posted yet for this study

Summary

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).

Conditions

  • End-stage Kidney Disease
  • CD4 T Cells
  • Central Memory T Cells
  • Regulatory T Cells
  • Uremic Toxins

Interventions

DEVICE

Polyamide HD membrane

Single use polyamide membrane

Sponsors & Collaborators

  • Research Unit CHCVs Hôpital de Sion Switzerland

    collaborator UNKNOWN

  • Immunology ICHV Sion Switzerland

    collaborator UNKNOWN

  • University of Lausanne Hospitals

    collaborator OTHER

  • Centre Hospitalier du Centre du Valais

    lead OTHER

Principal Investigators

  • Pascal Meier, MD · Nephrology service CHCVs Hôpital de Sion/Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01103076 on ClinicalTrials.gov