A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients

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: NCT01897688
Recruitment Status : Active, not recruiting
First Posted : July 12, 2013
Last Update Posted : December 11, 2018
Information provided by (Responsible Party):
Xunrong Luo, Northwestern University

Brief Summary:
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Severe Hypoglycemic Unawareness Biological: Islet Cell Transplant Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Single Center Study of Islet Transplantation in Non-uremic Diabetic Patients
Study Start Date : June 2012
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Islet Cell Transplant
All qualified subjects will be put on United Network for Organ Sharing (UNOS) Islet Transplant wait list for potential islet cell transplant.
Biological: Islet Cell Transplant

Primary Outcome Measures :
  1. To demonstrate the safety and efficacy of islet transplantation under alemtuzumab induction for treatment of Type-1 Diabetes (T1D) in subjects with hypoglycemia unawareness and a history of severe hypoglycemic episodes. [ Time Frame: Two years after the final islet transplant. ]
    To assess the efficacy of islet cell transplantation under alemtuzumab induction immunosuppression on the proportion of subjects with a change in HbA1c and free of severe hypoglycemic events through two years after the final islet transplant.

Secondary Outcome Measures :
  1. To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics [ Time Frame: Two years after the final islet transplant. ]
    To assess the proportion of insulin-independent subjects at two years after the final islet transplant.

  2. To relate clinical transplant outcomes based upon islet quantity/quality to organ donor characteristics. [ Time Frame: Two years after the final islet transplant. ]
    To compare islet graft outcome between alemtuzumab induction and historical anti-thymocyte induction groups.

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

Inclusion Criteria

  1. Male and female patients age 18-65 years of age at consent
  2. Ability to provide written informed consent
  3. Mentally stable and able to comply with the procedures of the study protocol
  4. Patients with T1D and insulin-dependent for at least 5 years fulfilling the following criteria:

    1. Absent stimulated c-peptide (<0.3 ng/mL) in response to a mixed meal tolerance test (MMTT; ensure 6 mL/kg body weight to a maximum of 360mL) measured at 60 and 90 min after the start of consumption
    2. Patients who have been followed by a qualified physician for diabetes management for a minimum of 12 months
    3. At least one episode of severe hypoglycemia in the past 12 months
    4. A Clarke score of 4 or more defining reduced awareness of hypoglycemia
  5. Or, previous islet cell transplant recipients who have returned to partial or full insulin usage and are taking maintenance immunosuppression medications.

Exclusion Criteria

  1. Body mass index (BMI) > 30
  2. Insulin requirement of > 1.0 IU/kg/day
  3. HbA1c > 10%
  4. Calculated glomerular filtration rate (GFR) < 80mL/min for transplant-naïve patients (using subjects serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration equation CKD-EPI) or 50mL/min for previously transplanted patients currently on immunosuppression
  5. Macroalbuminuria >300 mg/g creatinine
  6. Panel reactive anti-HLA antibodies> 50% by flow cytometry
  7. For female subjects: positive pregnancy test, breast feeding or unwillingness to use effective contraceptive measures for the duration of the study.
  8. Active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB)
  9. Negative Epstein-Barr Virus (EBV) by IgG
  10. Any history of malignancy except resected squamous or basal cell carcinoma
  11. Alcohol or substance abuse
  12. Baseline Hb below the lower limit of normal
  13. International normalized ratio >1.5 and long term anticoagulant therapy
  14. Clinically significant coronary artery disease
  15. Elevated liver function tests >1.5 times upper limit of normal
  16. Symptomatic cholecystolithiasis
  17. Gastrointestinal disorders interfering with ability to absorb oral medications
  18. Uncontrolled hyperlipidemia (LDL cholesterol >130 mg/dL and/or triglycerides >200 mg/dL)
  19. Chronic corticosteroid use

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): NCT01897688

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Xunrong Luo, MD, PhD Northwestern University

Responsible Party: Xunrong Luo, Principal Investigator, Northwestern University Identifier: NCT01897688     History of Changes
Other Study ID Numbers: STU00059469
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Keywords provided by Xunrong Luo, Northwestern University:

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms