ALANINE, ARGININE, DEFEROXAMINE, HISTIDINE, ASPARTIC ACID, GLYCINE, TRYPTOPHAN, SUCROSE, CALCIUM, MAGNESIUM, POTASSIUM, SODIUM, N-HYDROXY-3,4-DIMETHOXY-N-METHYL-BENZAMIDE, N-ACETYLHISTIDINE, CHLORIDE ION, OXOGLURIC ACID for Kidney transplantation | Liver transplantation | Kidney–pancreas transplantation

Inclusion criteria

• {"criterion_text":"- Donor criteria - For All patients undergoing deceased donation: - deceased adult (≥18 years) donors fulfilling the criteria for organ donation\n- donor criteria - For All patients undergoing living kidney donation: - adult (≥18 years) living kidney donors fulfilling the criteria for organ donation\n- recipients awaiting their transplant\n- recipients ≥18 years\n- recipients' signed informed consent before the transplantation\n- Liver recipient - full organ transplantation"}

Exclusion criteria

• {"criterion_text":"- All organs (kidney, combined kidney – pancreas and liver) Donor criteria ( not applicable for living kidney donors ) - donors whose organs are all allocated out of retrieving study center\n- According to the KDIGO-Guidelines (2009) all patients with PRA >0% are only included in the living donation setting.\n- Liver recipient - re-transplantation\n- - general refusal of organ donation\n- - donation after cardiac death (DCD)\n- - pregnant or lactating patients\n- recipients participating in any interventional study (e.g. another study involv-ing compound/interventions aimed at the reduction of preservation and/or is-chemia/reperfusion injury)\n- - all combined allocations other than pancreas and kidney\n- double kidney transplantation\n- - pancreas re-transplantation\n- - machine perfusion"}

Primary endpoints

• {"endpoint_text":"- kidney: delayed graft function has been picked as the main endpoint","definition_or_measurement_approach":""}
• {"endpoint_text":"- liver: The success of liver transplantation is determined by the area under the curve of GPT (ALT) measurements over the first 7 days after implantation (AUC)","definition_or_measurement_approach":"Area under the curve of GPT (ALT) measurements over the first 7 days after implantation (AUC)"}

Secondary endpoints

• {"endpoint_text":"- Kidney 1. Incidence of primary poor function (creatinine at 3 month: >250  mol/l)","definition_or_measurement_approach":"Creatinine at 3 months: >250 µmol/l (defines primary poor function)"}
• {"endpoint_text":"- Kidney 2. Serum creatinine, creatinine MDRD clearance, urea, and hemoglobin after 3 months","definition_or_measurement_approach":"Laboratory measures at 3 months: serum creatinine, creatinine MDRD clearance, urea, hemoglobin"}
• {"endpoint_text":"- kidney 3. Requirement of dialysis until 3 month after transplantation","definition_or_measurement_approach":"Requirement of dialysis up to 3 months post-transplant"}
• {"endpoint_text":"- kidney 4. Biopsy proven rejections","definition_or_measurement_approach":"Biopsy-proven rejection episodes"}
• {"endpoint_text":"- 1. Absolute peak LDH within 7 days after transplantation","definition_or_measurement_approach":"Measure peak LDH within first 7 days post-transplant"}
• {"endpoint_text":"- liver 2. Moment (day) of peak GPT and peak LDH","definition_or_measurement_approach":"Day of peak GPT (ALT) and LDH after transplantation"}
• {"endpoint_text":"- liver 3. Serum bilirubin, GOT, GPT, LDH, total albumin and PT at 3 months","definition_or_measurement_approach":"Laboratory panel at 3 months: bilirubin, GOT, GPT, LDH, albumin, PT"}
• {"endpoint_text":"- liver 4. Biliary complications: number of episodes of cholestasis, therapy for chol-angitis, episodes of biliary leakage and intrahepatic and/or extrahepatic bil-iary strictures","definition_or_measurement_approach":"Count of biliary complication events (cholestasis, cholangitis therapy, leakage, strictures)"}
• {"endpoint_text":"- Pancreas 1. Insulin requirements on days 3 and 30 and after 3 months","definition_or_measurement_approach":"Insulin dose requirements measured on day 3, day 30 and at 3 months"}
• {"endpoint_text":"- pancreas 2. α-amylase, lipase, C-reactive protein (CRP) at 1 und 3 days","definition_or_measurement_approach":"Laboratory measures on day 1 and day 3: α-amylase, lipase, CRP"}
• {"endpoint_text":"- pancreas 3. C-peptide and HBA1c at day 30 and 3 months","definition_or_measurement_approach":"C-peptide and HbA1c measured at day 30 and at 3 months"}
• {"endpoint_text":"- pancreas 4. Pancreatic complications: graft pancreatitis, anastomotic leak, vascular complications (thrombosis, stenosis, bleeding)","definition_or_measurement_approach":"Count and classification of pancreatic graft complications"}
• {"endpoint_text":"- pancreas 5. Fasting glucose at 3 months","definition_or_measurement_approach":"Fasting glucose measurement at 3 months"}

Austria

Latest Decision Or Authorization Date

09-12-2025

Number Of Sites

4

Number Of Participants

362

Primary sponsor

Full Name

Dr. Franz Koehler Chemie GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany