Complement Inhibitor Eculizumab in Clinical Islet Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-15

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Islet Transplant for Type 1 or Surgical Diabetes

NCT01606475

Type 1 Diabetes Mellitus Hypoglycemia Labile Diabetes +1 more

NO_LONGER_AVAILABLE

Islet Transplantation in Type 1 Diabetic Kidney Allograft

NCT01241864

Diabetes Mellitus, Type 1

RECRUITING PHASE2

Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

NCT00679042

Type 1 Diabetes Mellitus

ACTIVE_NOT_RECRUITING PHASE3

Islet Transplantation in Type 1 Diabetes

NCT00434811

Type 1 Diabetes Mellitus

COMPLETED PHASE3

Islet Allotransplantation With Steroid Free Immunosuppression

NCT00446264

Type 1 Diabetes Hypoglycemia Metabolic Diseases

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Eculizumab

Intravenous infusion

Group Type EXPERIMENTAL

Eculizumab

Intervention Type DRUG

Intravenous infusion (1200 mg) over 35 minutes. Consecutive infusions (900 mg) on Days 1, 7 and 14.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eculizumab

Intravenous infusion (1200 mg) over 35 minutes. Consecutive infusions (900 mg) on Days 1, 7 and 14.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Soliris

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No