Status:
COMPLETED
Alemtuzumab Induction in Islet Transplantation
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Our experience suggests that further research with alemtuzumab is attractive in islet transplantation. Therefore, in this study we propose to combine alemtuzumab induction pre-transplant, with tacroli...
Detailed Description
This trial is a single-center, prospective, open-label study in 12 Type 1 diabetic participants receiving an islet-alone transplant along with alemtuzumab induction therapy followed by combination tac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00175253
Start Date
November 1 2005
End Date
April 1 2012
Last Update
July 12 2012
Active Locations (1)
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1
University of Alberta - Clinical Islet Transplant Program
Edmonton, Alberta, Canada, T6G2C8