Alemtuzumab Induction in Islet Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00175253
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : July 12, 2012
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Alberta

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 tacrolimus and mycophenolate mofetil maintenance immunosuppression post-transplant. In the critical early phase post transplant, we anticipate that this regimen will prove to be more effective in control of autoimmunity or rejection events, and have a more desirable side-effect profile, than previously tested combinations of induction and immunosuppressive agents.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: alemtuzumab Procedure: islet transplant Phase 2

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 tacrolimus and MMF maintenance immunosuppression. Participants will receive 1 to 3 infusions of pancreatic islets of sufficient quantity to attain insulin independence.

The primary objective of this protocol is to assess the safety of a treatment regimen utilizing alemtuzumab induction and a combination of tacrolimus and MMF maintenance immunosuppression in adult Type 1 diabetic participants receiving their first islet transplant.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alemtuzumab Induction With Tacrolimus and MMF Maintenance Immunosuppression in Islet Transplantation
Study Start Date : November 2005
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00175253

Canada, Alberta
University of Alberta - Clinical Islet Transplant Program
Edmonton, Alberta, Canada, T6G2C8
Sponsors and Collaborators
University of Alberta
Juvenile Diabetes Research Foundation
Principal Investigator: A.M. James Shapiro, MD, PhD University of Alberta

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Alberta Identifier: NCT00175253     History of Changes
Other Study ID Numbers: 5369
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012

Keywords provided by University of Alberta:

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents