Complement Inhibitor Eculizumab in Clinical Islet Transplantation

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University
• Treatments: Complement Inactivating Agents; Complement System Proteins; Eculizumab

Criteria

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