Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet Transplantation

Completed · Phase 1/Phase 2

Conditions studied: Type 1 Diabetes Mellitus, Hypoglycemia

In brief

This study was designed to test the safety and efficacy of up to 3 pancreatic alloislet transplants in type 1 diabetic patients with hypoglycemia unawareness. 6 subjects were transplanted under this protocol using anti-thymocyte globulin induction immunosuppression and everolimus with cyclosporine maintenance immunosuppression.

Key facts

Study ID

NCT00286624

Run by

University of Minnesota

People needed

6

Starts

2003-03-01

Expected to finish

2006-08-01

Last updated by the study team

2008-05-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary islet allotransplant
• Patients with type 1 diabetes mellitus under intensive insulin management
• Age 18 or older
• Ability to give written informed consent

You may not qualify if…

• Age less than 18 years.
• BMI >26 kg/m2.
• Insulin requirement of > 50 IU per day.
• Positive C-peptide response to intravenous arginine stimulation.
• Untreated proliferative retinopathy.
• Creatinine clearance < 60 ml/min/1.73 m2 for females and 70 ml/min/1.73 m2 for males.
• Serum creatinine >1.3 mg/dl for females, >1.5 mg/dl for males.
• Previous pancreas or islet transplant.
• Presence of history of panel-reactive anti-HLA antibodies >10%.
• Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures.
• Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB).
• Negative screen for Epstein-Barr Virus (EBV).
• Invasive aspergillus infection within year prior to study entry.
• History of malignancy.
• Active alcohol or substance abuse
• History of non-adherence to prescribed regimens.
• Psychiatric disorder making the subject not a suitable candidate for transplantation.
• Inability to provide informed consent.
• Baseline Hgb < 11.7 g/dl in females, or < 13 g/dl in males; lymphopenia (<1,000/microL), or leukopenia (<3,000 total leukocytes/microL), or an absolute CD4+ count <500/microL., or platelets <150,000/microL
• History of coagulopathy or medical condition requiring long-term anticoagulant therapy after transplantation or patient with INR >1.5.
• Severe co-existing cardiac disease.
• Baseline liver function tests outside of normal range or history of significant liver disease.
• Active peptic ulcer disease.
• Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications.
• Presence of severe allergy requiring acute or chronic treatment, or hypersensitivity to drugs similar to RAD (e.g., macrolides).

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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