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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Treatments: Eculizumab

Criteria

Inclusion Criteria:

1. Adults with an atypical Hemolytic and Uremic Syndrome defined by at least 2 of the following parameters:

• Thrombopenia (platelet count < 150 G/L)

• Mechanical lytic anemia (Hb < 10 g/L, Lactate dehydrogenase > upper limit of normal, undetectable haptoglobin, presence of schistocytes on blood smear)

• Acute renal failure

2. Eculizumab treatment

• Without project of withdrawal in the next 18 months

• Started since at least 6 months

• Administrated with an unchanged administration schedule since at least 3 months (initial episode or relapse)

3. Atypical Hemolytic and Uremic Syndrome in remission

4. Patients who give informed consent.

Exclusion Criteria:

1. Patients on dialysis.

2. Women treated starting or planning a pregnancy.

3. Patients suffering from a typical or secondary microangiopathic hemolytic anemia (drugs, malignancies, autoimmune disease...)

4. Patients under protection of a judicial authority