Status:
COMPLETED
LEA29Y (Belatacept) Emory Edmonton Protocol
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Clinical Islet Transplantation Consortium
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
Detailed Description
Type 1 diabetes is commonly treated with the administration of insulin, either by multiple insulin injections or by a continuous supply of insulin through a wearable pump. Insulin therapy allows long-...
Eligibility Criteria
Inclusion
- Mentally stable and able to comply with study procedures
- Clinical history compatible with type 1 diabetes with onset of disease at less than 40 years of age, insulin dependence for at least 5 years at study entry, and a sum of age and insulin dependent diabetes duration of at least 28
- Absent stimulated C-peptide (less than 0.3 ng/mL) 60 and 90 minutes post-mixed-meal tolerance test
- Involvement of intensive diabetes management, defined as:
- Self-monitoring of glucose no less than a mean of three times each day averaged over each week
- Three or more insulin injections each day or insulin pump therapy
- Under the care of an endocrinologist, diabetologist, or diabetes specialist with at least three clinical evaluations during the past 12 months prior to study enrollment
- At least one episode of severe hypoglycemia, defined as an event with one of the following symptoms: memory loss; confusion; uncontrollable behavior; irrational behavior; unusual difficulty in awakening; suspected seizure; seizure; loss of consciousness; or visual symptoms, in which the participant was unable to treat him/herself and which was associated with either a blood glucose level less than 54 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagons in the 12 months prior to study enrollment
- Reduced awareness of hypoglycemia. More information about this criterion is in the protocol.
Exclusion
- Body mass index (BMI) greater than 30 kg/m\^2 or weight less than or equal to 50 kg (110 lbs)
- Insulin requirement of more than 1.0 IU/kg/day or less than 15 U/day
- HbA1c greater than 10%
- Untreated proliferative diabetic retinopathy
- Systolic blood pressure higher than 160 mmHg or diastolic blood pressure higher than 100 mmHg
- Measured glomerular filtration rate using iohexol of less than 80 mL/min/1.73m\^2.
- Presence or history of macroalbuminuria (greater than 300 mg/g creatinine)
- Presence or history of panel-reactive anti-Histocompatibility Antigen (HLA) antibody levels greater than background by flow cytometry. More information about this criterion is in the protocol.
- Pregnant, breastfeeding, or unwilling to use effective contraception throughout the study and 4 months after study completion
- All women more than 35 years and women of any age who have first degree relatives with a history of breast carcinoma or who have other risk factors of breast carcinoma. More information about this criterion is in the study protocol.
- Active infection, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV). Presence or history of tuberculosis. More information about these criteria is in the protocol.
- Negative for Epstein-Barr virus (EBV) by anti-viral capsid antigen (VCA) IgG (EBV VCA-IgG) determination
- Invasive aspergillus, histoplasmosis, or coccidioidomycosis infection in the past year
- History of malignancy except for completely resected squamous or basal cell carcinoma of the skin
- Known active alcohol or substance abuse
- Baseline Hgb below the lower limits of normal, lymphopenia, neutropenia, or thrombocytopenia
- History of Factor V deficiency
- Any coagulopathy or medical condition requiring long-term anticoagulant therapy after transplantation or individuals with an international normalized ratio (INR) greater than 1.5.
- Severe coexisting cardiac disease, defined as:
- Heart attack within the last 6 months
- Evidence of ischemia on functional heart exam within the year prior to study entry
- Left ventricular ejection fraction less than 30%
- Persistent elevation of liver function tests at study entry
- Symptomatic cholecystolithiasis
- Acute or chronic pancreatitis
- Symptomatic peptic ulcer disease
- Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with the ability to absorb oral medications
- Hyperlipidemia despite medical therapy, defined as fasting LDL cholesterol greater than 130 mg/dL and/or fasting triglycerides greater than 200 mg/dL
- Currently receiving treatment for a medical condition that requires chronic use of systemic steroids except for the use of 5 mg or less of prednisone daily, or an equivalent dose of hydrocortisone, for physiological replacement only
- Treatment with any antidiabetic medication other than insulin within the past 4 weeks
- Previous receipt of belatacept
- Use of any investigational agents within the past 4 weeks
- Received a live attenuated vaccine(s) within the past 2 months
- Any medical condition that, in the opinion of the investigator, might interfere with safe participation in the trial
- Treatment with any immunosuppressive regimen at the time of enrollment.
- A previous islet transplant.
- A previous pancreas transplant, unless the graft failed within the first week due to thrombosis, followed by pancreatectomy and the transplant occurred more than 6 months prior to enrollment.
- Known hypersensitivity to mycophenolate mofetil or any of its components
- Imprisonment or involuntary incarceration for treatment of either a psychiatric or physical illness
- Rare hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and Kelly-Seegmiller syndrome
- Dietary restriction of phenylalanine
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00468403
Start Date
October 1 2008
End Date
April 1 2013
Last Update
April 7 2016
Active Locations (2)
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1
Emory University
Atlanta, Georgia, United States, 30322
2
University of Alberta
Edmonton, Alberta, Canada, T6G028