Personalized Spacing of Eculizumab Infusions Based on Therapeutic Pharmacological Monitoring (EspacECU)

Summary

Eculizumab is an anti-C5 monoclonal antibody approved for rare diseases including atypical haemolytic-uraemic syndrome. The maintenance phase dosing regimen is identical for all adult patients but several studies have shown a high interindividual kinetics variability. A tailored administration of eculizumab based on therapeutic drug monitoring will be compared with real-life administration in adults suffering from an atypical haemolytic uraemic syndrome. The objective is to improve efficiency of eculizumab administration.

Conditions

• Hemolytic-Uremic Syndrome, Atypical

Interventions

DRUG

Spacing of Eculizumab infusions

Personalized spacing of eculizumab infusions using a pharmacokinetic population model to estimate eculizumab concentration ( a one-week spacing of eculizumab infusion will be decide if predicted eculizumab concentration in the event of spacing is \> 150 mg/L). Spacing of infusion can be decided every 3 months.

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens

  collaborator OTHER

• University Hospital, Angers

  collaborator OTHER_GOV

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• University Hospital, Caen

  collaborator OTHER

• Centre Hospitalier of Chartres

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• University of Nancy

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• University Hospital, Rouen

  collaborator OTHER

• University Hospital, Strasbourg, France

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• Tenon Hospital, Paris

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• Reims University hospital

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  collaborator OTHER

• Assistance Publique Hopitaux De Marseille

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• University Hospital, Tours

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-20

Primary Completion

2022-06-16

Completion

2023-12-28

Countries

• France

Study Locations