hOKT3γ1 (Ala-Ala) Combined With Sirolimus and Delayed Tacrolimus in Type 1 Diabetic Islet Allograft Recipients

Completed · Phase 1/Phase 2

Conditions studied: Type 1 Diabetes, Hypoglycemia

In brief

The collective effects of two-layer pancreas preservation, pretransplant islet culture, day -2 pretransplant immunosuppression, and induction immunosuppression with the FcR-nonbinding anti-CD3 monoclonal antibody hOKT3γ1 (Ala-Ala)to facilitate diabetes reversal after single-donor islet transplantation.

Key facts

Study ID

NCT00285194

Run by

University of Minnesota

People needed

6

Starts

2000-04-01

Expected to finish

2004-01-01

Last updated by the study team

2012-08-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Primary islet allotransplant
• Type 1 diabetes mellitus, complicated by at least one of the following situations that persist despite intensive efforts in close cooperation with their diabetes care team:
• Metabolic lability/instability;
• Reduced awareness of hypoglycemia;
• Persistently poor glucose control (as defined by HgbA1c>10% at the end of six months of intensive management efforts with the diabetes care team);
• Progressive secondary complications.
• Age 18 and older
• Able to give written informed consent

You may not qualify if…

• Age less than 18 years
• Body weight greater than75 kg.
• BMI greater than 26 kg/m2 for male and females
• Waist-to-hip ratio 0.80 (female) and 0.95 (male)
• First degree relative with type 2 diabetes
• Insulin requirement of greater than 0.7 IU/kg/day
• HbA1C greater than 12%
• Positive C-peptide response to intravenous arginine stimulation
• Untreated proliferative retinopathy
• Macroalbuminuria (urinary albumin excretion greater than 300 mg/24hrs)
• Creatinine clearance greater than 85 ml/min/1.73 m2 in females, greater than 95 ml/min/1.73 m2 in males
• Serum creatinine greater than 1.2 mg/dl
• Previous pancreas or islet transplant
• Previous OKT3 antibody therapy
• Presence of history of panel-reactive anti-HLA antibodies greater than 10%
• Abnormal T4 and TSH despite thyroid replacement therapy
• Positive pregnancy test, or presently breast-feeding
• Active infection
• Negative screen for Epstein-Barr Virus (EBV) by an EBNA method
• Invasive aspergillus infection within year prior to study entry
• Any 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
• Karnofsky performance score greater than 70

Where it is running

• Universtiy of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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