NCT04742374

Brief Summary

CIDP, a rare disorder affecting young adults, causes gradual weakness of the limbs, areflexia and impaired sensory function. New CIDP phenotypes without antibodies but with modified cell profiles have been described. Treatments include corticotherapy, IVIg and plasmapheresis but the latter's action mechanisms remain unclear. Plasmapheresis supposedly removes toxic agents like antibodies from plasma but it is uncertain whether it has an immune-modulating effect. Also, the refining mechanisms of the two main plasmapheresis techniques - single plasma exchange and double filtration plasmapheresis (DFPP) - are different and unclear. This study aims to compare the evolution of peripheral lymphocyte profiles in patients with CIDP according to their treatment (single centrifugation plasmapheresis or DFPP) to better grasp the action mechanisms of both techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2021

Typical duration for early_phase_1

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

January 26, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 12, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2023

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

2.8 years

First QC Date

January 26, 2021

Last Update Submit

December 3, 2025

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Keywords

Plasma exchangeDouble filtration plasmapheresis

Outcome Measures

Primary Outcomes (108)

  • Cycle 1, Group A : TH1 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Time 0

  • Cycle 1, Group A : TH1 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 1, Group A : TH1 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7 -10

  • Cycle 1, Group A : TH17 cells BEFORE first single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH17 peripheral lymphocyte cells will be measured in %.

    Day 0, Time 0

  • Cycle 1, Group A : TH17 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 1, Group A : TH17 cells 7 - 10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 peripheral lymphocyte cells will be measured in %.

    Day 7 - 10

  • Cycle 1, Group A : T-reg cells BEFORE first single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 1, Group A : T-reg cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 1, Group A : T-reg cells 7 - 10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 7 - 10

  • Cycle 1, Group B : TH1 cells BEFORE first double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 0

  • Cycle 1, Group B : TH1 cells AFTER the first double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 1, Group B : TH1 cells 7-10 days AFTER the first double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7 - 10

  • Cycle 1, Group B : TH17 cells BEFORE the first double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day0, Hour 0

  • Cycle 1, Group B : TH17 cells AFTER the first double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 1, Group B : T17 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 7-10

  • Cycle 1, Group B : T-reg cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 1, Group B : T-reg cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 1, Group B : T-reg cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 7 - 10

  • Cycle 2, Group A: TH1 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH1 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 2, Group A: TH1 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 2, Group A: TH1 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 cells will be measured in %.

    Day 7 - 10

  • Cycle 2, Group A: TH17 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 2, Group A: TH17 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 2, Group A: TH17 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 7-10

  • Cycle 2, Group A: T-reg cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 2, Group A: T-reg cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 2, Group A: T-reg cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 7-10

  • Cycle 2, Group B: TH1 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH1 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 2, Group B: TH1 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 2, Group B: TH1 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 cells will be measured in %.

    Day 7-10

  • Cycle 2, Group B: T17 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of T17 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 2, Group B: TH17 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 2, Group B: TH17 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 7-10

  • Cycle 2, Group B: T-reg cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 2, Group B: T-reg cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 2, Group B: T-reg cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 7-10

  • Cycle 3, Group A: TH1 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 1, Hour 1

  • Cycle 3, Group A: TH1 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 1, Hour 3

  • Cycle 3, Group A: T1 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7 - 10

  • Cycle 3, Group A: TH17 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH17 cells will be measured in %.

    Day 1, Hour 1

  • Cycle 3, Group A: TH17 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 1, Hour 3

  • Cycle 3, Group A: TH17 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 7 - 10

  • Cycle 3, Group A: T-reg cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 3, Group A: T-reg cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 3, Group A: T-reg cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 7-10

  • Cycle 3, Group B: TH1 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 0

  • Cycle 3, Group B: TH1 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 3, Group B: TH1 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7-10

  • Cycle 3, Group B: TH17 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 3, Group B: TH17 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 3, Group B: TH17 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 7-10

  • Cycle 3, Group B: T-reg cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 3, Group B: T-reg cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 3, Group B: T-reg cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 7-10

  • Cycle 4, Group A: T1 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of T1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 0

  • Cycle 4, Group A: T1 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 4, Group A: TH1 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7 - 10

  • Cycle 4, Group A: TH17 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 4, Group A: TH17 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 4, Group A: TH17 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 peripheral lymphocyte cells will be measured in %.

    Day 7 - 10

  • Cycle 4, Group A: T-reg cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 4, Group A: T-reg cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 4, Group A: T-reg cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg peripheral lymphocyte cells will be measured in %.

    Day 7 - 10

  • Cycle 4, Group B : TH1 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 0

  • Cycle 4, Group B : TH1 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 4, Group B : TH1 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7 -10

  • Cycle 4, Group B : TH17 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH17 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 4, Group B : TH17 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 4, Group B : T17 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T1 peripheral lymphocyte cells will be measured in %.

    Day 7 -10

  • Cycle 4, Group B : T-reg cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 4, Group B : T-reg cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 4, Group B : T-reg cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 7 - 10

  • Cycle 5, Group A : TH1 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 0

  • Cycle 5, Group A : TH1 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 5, Group A : TH1 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 cells will be measured in %.

    Day 7 - 10

  • Cycle 5, Group A : TH17 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH17 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 5, Group A : TH17 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 5, Group A : TH17 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 7 - 10

  • Cycle 5, Group A : T-reg cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 5, Group A : T-reg cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 5, Group A : T-reg cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 7 - 10

  • Cycle 5, Group B : TH1 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 0

  • Cycle 5, Group B : TH1 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0, Hour 3

  • Cycle 5, Group B : TH1 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7-10

  • Cycle 5, Group B : TH17 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 0

  • Cycle 5, Group B : TH17 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0, Hour 3

  • Cycle 5, Group B : TH17 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 7-10

  • Cycle 5, Group B : T-reg cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 0

  • Cycle 5, Group B : T-reg cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0, Hour 3

  • Cycle 5, Group B : T-reg cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 7-10

  • Cycle 6, Group A : TH1 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0 Hour 0

  • Cycle 6, Group A : TH1 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0 Hour 3

  • Cycle 6, Group A : TH1 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube 7-10 days AFTER double filtration plasmapheresis and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7-10

  • Cycle 6, Group A : TH17 cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0 Hour 0

  • Cycle 6, Group A : TH17 cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 0 Hour 3

  • Cycle 6, Group A : TH17 cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube 7-10 days AFTER double filtration plasmapheresis and the number of TH17 cells will be measured in %.

    Day 7-10

  • Cycle 6, Group A : T-reg cells BEFORE double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube BEFORE double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0 Hour 0

  • Cycle 6, Group A : T-reg cells AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 0 Hour 3

  • Cycle 6, Group A : T-reg cells 7-10 days AFTER double filtration plasmapheresis

    5 mL of blood will be collected in an EDTA tube 7-10 days AFTER double filtration plasmapheresis and the number of T-reg cells will be measured in %.

    Day 7-10

  • Cycle 6, Group B : TH1 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0 Hour 0

  • Cycle 6, Group B : TH1 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 0 Hour 3

  • Cycle 6, Group B : TH1 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH1 peripheral lymphocyte cells will be measured in %.

    Day 7-10

  • Cycle 6, Group B : TH17 cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of TH17 cells will be measured in %.

    Day 0 Hour 0

  • Cycle 6, Group B : TH17 cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 0 Hour 3

  • Cycle 6, Group B : TH17 cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of TH17 cells will be measured in %.

    Day 7-10

  • Cycle 6, Group B : T-reg cells BEFORE single plasma exchange

    5 mL of blood will be collected in an EDTA tube BEFORE single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0 Hour 0

  • Cycle 6, Group B : T-reg cells AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 0 Hour 3

  • Cycle 6, Group B : T-reg cells 7-10 days AFTER single plasma exchange

    5 mL of blood will be collected in an EDTA tube AFTER single plasma exchange and the number of T-reg cells will be measured in %.

    Day 7-10

Secondary Outcomes (324)

  • Cycle 1, Group A : T4 lymphocytes BEFORE single plasma exchange

    Day 0 Hour 0

  • Cycle 1, Group A : T4-DR+ lymphocytes BEFORE single plasma exchange

    Day 0 Hour 0

  • Cycle 1, Group A : T8 lymphocytes BEFORE single plasma exchange

    Day 0 Hour 0

  • Cycle 1, Group A : T8 DR+ lymphocytes BEFORE single plasma exchange

    Day 0 Hour 0

  • Cycle 1, Group A : B lymphocytes BEFORE single plasma exchange

    Day 0 Hour 0

  • +319 more secondary outcomes

Other Outcomes (28)

  • Group A, Cycle 1 : Link between variations in lymphocyte sub-populations and the clinical evolution .

    Day 7-10 after the end of Cycle 1 (each cycle lasts 3 hours)

  • Group B, Cycle 1 : Link between variations in lymphocyte sub-populations and the clinical evolution .

    Day 7-10 after the end of Cycle 1 (each cycle lasts 3 hours)

  • Group A, Cycle 2 : Link between variations in lymphocyte sub-populations and the clinical evolution .

    Day 7-10 after the end of Cycle 2 (each cycle lasts 3 hours)

  • +25 more other outcomes

Study Arms (2)

Group A

EXPERIMENTAL

Patients alternating single plasma exchange followed by double filtration plasmapheresis etc.

Biological: Blood sampling

Group B

EXPERIMENTAL

Patients alternating double filtration plasmapheresis followed by single plasma exchange etc.

Biological: Blood sampling

Interventions

Blood samplingBIOLOGICAL

Blood sampling before and after each type of cycle, Single Plasma Exchange or Double Filtration Plasmapheresis

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • Patients with confirmed Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) without pathogenic antibodies and stable under therapeutic plasmapheresis with one session every 2-3 weeks for at least two months.
  • Patients who have given free written informed consent.
  • Patients who have signed the consent form.
  • Patients affiliated to or beneficiaries of a health insurance scheme.
  • Adult patients (≥18 ans).
  • Healthy subjects of the same age and sex

You may not qualify if:

  • Patients Under the age of 18.
  • Patients under immunosuppressive treatment for less than 3 months.
  • Patients participating in Category 1 research involving human subjects.
  • Patients under legal protection, guardianship or curatorship.
  • Patients unable to express consent.
  • Patients for whom it is impossible to give informed information.
  • Pregnant, parturient or breastfeeding patients.
  • Healthy subject with chronic pathology or drug treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Olivier MORANNE

Nîmes, France

Location

Related Publications (1)

  • Moranne O, Ion IM, Cezar R, Messikh Z, Prelipcean C, Chkair S, Thouvenot E, Tran TA, Corbeau P, Chevallier T. Protocol of comparison of the effects of single plasma exchange and double filtration plasmapheresis on peripheral lymphocyte phenotypes in patients with Chronic Inflammatory Demyelinating Polyradiculoneuropathy: a monocentric prospective study with single-case experimental design. BMC Neurol. 2022 Aug 5;22(1):293. doi: 10.1186/s12883-022-02816-w.

    PMID: 35931957BACKGROUND

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomisation to one of two treatments before alternation.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Proof-of-concept, monocentric, prospective, Single-Case Experimental Design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 8, 2021

Study Start

March 12, 2021

Primary Completion

December 18, 2023

Study Completion

December 18, 2023

Last Updated

December 10, 2025

Record last verified: 2025-12

Locations

FR(1)