A EUROPEAN MULTICENTER OPEN-LABEL RANDOMIZED TRIAL TO EVALUATE THE REDUCTION OF ISCHEMIA / REPERFUSION INJURY AFTER DE NOVO SIMULTANEOUS PANCREAS/KIDNEY TRANSPLANTATION IN TYPE 1-DIABETIC PATIENTS COMPARING A CONTROL GROUP VERSUS TREATMENT WITH PER-OPERATIVE N ACETYLCYSTEINE AND ANTITHROMBIN III VERSUS N ACETYLCYSTEINE ALONE

Centre Hospitalier Universitaire de Liège0 个研究点目标入组 123 人开始时间: 2010年5月12日最近更新: 2022年5月2日

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•Male or female patients, of 18 to 55 years of age, with pre or end-stage renal failure, C-peptide-negative, Type 1-diabetic nephropathy.
•Female patients of childbearing age must have a negative pregnancy test and must agree to maintain effective birth control practice throughout the study period (1 year).
•Patient must have signed the Patient Informed Consent Form.
•Patient must receive a primary simultaneous pancreas/kidney (SPK) cadaver transplant, with either intestinal or bladder and either portal or systemic venous drainages.
•The cold preservation solution must be UW or HTK.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patient is pregnant or breastfeeding.
•Patient is allergic or intolerant to Mycophenolate Mofetil, Tacrolimus or other macrolides, or any compounds structurally related to these compounds.
•Patient has a positive T-cell crossmatch on the most recent serum specimen.
•Patient is known for active liver disease or has significant liver disease defined by ASAT and ALAT serum levels greater than 3 times the upper limit of normal.
•Patient has history of prothrombotic disorders.
•Patient has malignancy or history of malignancy, with the exception of adequately treated localized squamous cell or basal cell carcinoma, without recurrence.
•Patient has been included in another clinical trial protocol for any investigational drug within 4 weeks prior to randomization.
•Patient has any form of substance abuse, psychiatric disorder or condition, which, in the opinion of the investigator, may invalidate communication.
•Patient receives a SPK transplant from a living donor, or receives segmental pancreatic transplant, or a previous kidney transplant alone.
•Pancreatic duct occlusion technique.
•Donor is older than 55 years of age.
•The use of any other commercial or investigational immunosuppressive drugs is prohibited if it is not clinically indicated.
•Patient has an immunological high risk, defined as a PRA grade > 30%

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