Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic REnal fAilure Stage Study

Exclusion Criteria

• •Patients will be excluded from participating if any of the following criteria apply:
• •Patient with any type 2 diabetes and/or fasting plasma C-peptide above 0.5 ng/ml.
• •Pregnant woman or breast-feeding mothers.
• •Woman of childbearing potential unwilling to maintain effective birth control during first year of the study
• •Second transplant recipient or recipient with a functional grafted organ.
• •Proteinuria below 300 mg/day (a mean from 3 samples).
• •Albuminemia less than 30 g/l.
• •Cystatin C and/or Cr51-EDTA and/or DMSA-Tc scintigraphy measured glomerular filtration rate lower than 60 ml/min or higher than 90 ml/min.
• •Presence of any documented non-diabetic systemic disease potentially affecting the kidney.
• •Known allergy, hypersensibility or intolerance to any known insulin, to any of the recommended immunosuppressive agents of the study (Thymoglobulin, anti-lymphocyte serum Fresenius, tacrolimus, cyclosporin, mycophenolate mofetil, mycophenolic acid, corticosteroids etc), mocrolides antibiotics, or to any compound or excipient of all these products.
• •Currently participating in another clinical trial and/or has taken an investigational drug within four weeks prior enrolment.
• •Diagnosis of new-onset malignancy during 5 years before enrolment.
• •Significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
• •Patient affected by active B hepatitis (HBsAg positive, HBeAg positive or HBV-DNA positive) or by active C hepatitis (HCVAb positive; HCV-RNA positive).
• •Patient HIV positive.
• •Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
• •Obesity (body mass index above than 30 kg/m2).
• •Severe iliac vessel calcifications impeding surgery.
• •Advanced coronary artery disease
• •Left ventricular function less than 30%.
• •Plasma blood leukocytes less than 2,000 /mm3 or higher than 15,000/mm3
• •Plasma blood platelets less 60,000 /mm3 or higher than 500,000/mm3
• •Psychological disorders influencing drug compliance.
• •Unable, unwilling or unlikely to comply fully with the protocol or the visits scheduled.