End-stage, C-peptide-negative, type 1-diabetic patients undergoing a first combined pancreas/kidney transplantation from a cadaver donor only will be enrolled in the study
Conditions
Interventions
Trade Name: Atenativ
Product Name: Atenativ
Pharmaceutical Form: Powder and solvent for solution for infusion
CAS Number: 0
Other descriptive name: HUMAN COAGULATION FACTOR VII
Concentration unit: IU
Sponsors
Centre Hospitalier Universitaire de Liège
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of the Antithrombin III and N Acetylcysteine in reducing the ischemia / reperfusion injury in Type 1-diabetic patients undergoing simultaneous pancreas/kidney allograft transplantation;Secondary Objective: To evaluate the impact of ischemia / reperfusion injury on graft function and on immunogenicity;Primary end point(s): Pancreas graft reperfusion pancreatitis measured by peak serum lipase between day 0 and day 4. | — |
Countries
Belgium
Outcome results
None listed