Complement Inhibitor Eculizumab in Clinical Islet Transplantation (ICC)

Uppsala University

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Eculizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02727608

ICC version 2

2014-005421-12 (EudraCT Number)

Details and patient eligibility

About

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant.

Full description

This is a dual centre, single arm, exploratory study of the possibility to use eculizumab (Soliris) to prevent/reduce destruction of islets of Langerhans after portal infusion of the islets in patients with diabetics accepted for islet transplant. Ten patients from 2 centres (Uppsala University Hospital and Karolinska University Hospital in Stockholm) will be transplanted. The purpose of the study is to investigate if selective complement inhibition by eculizumab combined with standard anticoagulation during and after transplantation can further reduce the extent of early tissue loss after portal infusion of islets.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18 to 65 years of age
• Patients able to provide written informed consent
• Absent stimulated c-peptide (< 0.1 nmol/L). This includes also previously islet-transplanted patients with no detectable c-peptide.
• Patients at fear of severe hypoglycemia
• Female patients of child bearing potential must have a negative pregnancy test (s-β-HCG) and must be practicing an effective, reliable medical accepted contraceptive regimen while on eculizumab treatment and to study end at 75 days.
• Patients vaccinated against Neisseria meningitides or patients accepting adequate antibiotic prophylaxis

Exclusion criteria

• Body mass index > 30 kg/m2
• Untreated proliferative diabetes retinopathy
• Recipient of any other concomitant organ transplantation - Glomerular filtration rate < 50 mL/min before first islet transplantation
• Positive T-cell cross-matching by Complement Depending Cytotoxicity (CDC)
• Pregnancy or lactating
• Active ongoing infection, bacterial or viral
• Unresolved meningococcal disease
• Known bleeding disorder
• Known complement disorder
• Have received any other investigational drug within 30 days before inclusion
• History of drug or alcohol abuse within the last year

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Eculizumab

Experimental group

Description:

Intravenous infusion

Treatment:

Drug: Eculizumab