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
- Conditions
- Type 1-diabetic patients undergoing simultaneous pancreas-kidney (SPK) allograft transplantation.
- Registration Number
- EUCTR2006-000845-21-DE
- Lead Sponsor
- niversity Hospital Innsbruck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine and compare the efficacy of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF therapy in conjunction with initial short-term steroids in Type 1-diabetic patients undergoing simultaneous pancreas-kidney allograft transplantation.;Secondary Objective: To evaluate the safety of Campath-1H/Tacrolimus versus ATG/Tacrolimus/MMF in terms of drug-related complications and immunosuppression-associated complications.;Primary end point(s): Biopsy-proven (kidney) rejection episodes (Banff Classification) after 1 year. A kidney or pancreas biopsy must be taken in case of suspected rejection of either kidney or pancreas. Biopsy analysis will be done according to BANFF 97 criteria. In all cases, a kidney biopsy should be obtained before initiating any anti-rejection therapy.
- Secondary Outcome Measures
Name Time Method