AN OPEN-LABEL; RANDOMIZED; PROSPECTIVE STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CAMPATH-1H AS AN INDUCTION AGENT IN COMBIANTION IWTH TACROLIMUS MONOTHERAPY COMPARED TO SHORT-COURSE ATG-INDUCTION IN COMBINATION WITH TACROLIMUS; MYCOPHENOLATE MOFETIL AND SHORT-TERM STEROIDS APPLICATION IN DE NOVO SPK TRANSPLANTED DIABETIC PATIENTS - SIMPATICO

niversity Hospital Innsbruck0 个研究点目标入组 60 人开始时间: 2006年5月22日最近更新: 2013年7月15日

适应症

试验速览

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•Male or female patients of 18 to 55 years of age with end-stage, 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 (3 years).
•Patient must have signed the Patient Informed Consent Form.
•Patient must receive a primary simultaneous pancreas-kidney (SPK) cadaveric transplant, with either intestinal or bladder and either portal or systemic venous drainages.
•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.
•Past history of anaphylaxis following exposure to humanized monoclonal antibodies.
•Patient has a positive T-cell crossmatch on the most recent serum specimen.
•CMV-match: D+ / R-.
•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 malignancy or history of malignancy, with the exception of adequately treated localised 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 randomisation.
•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.

发起方

niversity Hospital Innsbruck