Alemtuzumab Induction in Islet Transplantation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00175253
• Date of registration: 13/09/2005
• Primary sponsor: University of Alberta
• Public title: Alemtuzumab Induction in Islet Transplantation
• Scientific title: Alemtuzumab Induction With Tacrolimus and MMF Maintenance Immunosuppression in Islet Transplantation
• Date of first enrolment: November 2005
• Target sample size: 12
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00175253
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: A.M. James Shapiro, MD, PhD
• Affiliation: University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

- open to Canadians only

- participant must have had Type 1 diabetes mellitus for more than 5 years

- diabetes must be complicated by at least 1 of the following situations that persist
despite intensive insulin management efforts: (1) Reduced awareness of hypoglycemia,
as defined by the absence of adequate autonomic symptoms at plasma glucose levels <
3.0 mmol/L, indicated by, 2 or more episodes of severe hypoglycemia requiring third
party assistance within 12 months; or (2) Metabolic instability, characterized by
erratic blood glucose levels that interfere with daily activities and or 2 or more
hospital visits for diabetic ketoacidosis over the last 12 months.

- Participants must be capable of understanding the purpose and risks of the study and
must sign a statement of informed consent.

Exclusion Criteria:

- Severe co-existing cardiac disease

- Active alcohol or substance abuse, to include cigarette smoking

- Psychiatric disorder making the subject not a suitable candidate for transplantation

- History of non-adherence to prescribed regimens

- Active infection including Hepatitis C, Hepatitis B, HIV, TB

- Any history of or current malignancies except squamous or basal skin cancer

- BMI > 28 kg/m2 at screening visit

- Creatinine clearance < 65 mL/min/1.73 m2

- Blood creatinine > 150 µmol/L (1.7 mg/dL)

- Macroalbuminuria (urinary albumin excretion rate > 300 mg/24h)

- Baseline Hb < 105g/L (<10.5 g/dL) in women, or < 130 g/L (<13 g/dL) in men

- Baseline screening liver function tests outside of normal range

- Untreated proliferative retinopathy

- Positive pregnancy test, intent for future pregnancy or male subjects' intent to
procreate, failure to follow effective contraceptive measures, or presently breast
feeding

- Previous transplant, or evidence of significant sensitization on PRA

- Insulin requirement >1.0 U/kg/day

- HbA1C >12%

- Uncontrolled hyperlipidemia

- Under treatment for a medical condition requiring chronic use of steroids

- Use of coumadin or other anticoagulant therapy (except aspirin) or subject with PT
INR > 1.5

- Untreated Celiac disease

- Patients with Graves disease will be excluded unless previously adequately treated
with radioiodine ablative therapy



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Drug: alemtuzumab

Procedure: islet transplant

Secondary ID(s)

5369

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Juvenile Diabetes Research Foundation