FIH Phase I/IIa Trial Evaluating Safety of TUM012 to Minimize Ischemic Reperfusion Injury in Kidney Transplantation

Inclusion Criteria: * Standard and extended criteria donor ≥18 years of age, suitable for clinical transplantation and preserved by cold storage. * Available, personally signed and dated Informed Consent Form (ICF) * Male or female Chronic Kidney Disease (CKD) patient ≥18 years of age, with Glomerular Filtration Rate (GFR) ≤15 mL/min, awaiting their first kidney transplantation * ABO-compatible, negative pre-transplant CDC class I and II crossmatch with no Donor Specific Antibodies (DSA), defined as ≤1 000 Mean Fluorescent Intensity (MFI). * Patient is suitable for surgery, as judged by the investigator * Completed vaccination program for pneumococcal disease, varicella zoster, measles, and SARS-CoV-2 virus Exclusion Criteria: * Surgically induced injuries compromising ex-vivo treatment and/or transplant outcome, as judged by the transplantation surgeon * Previously undergone any organ and/or cell transplantations * Patients with positive CDC class I and/or II crossmatch, or negative CDC class I and II crossmatch with pre-existing DSA \> 1,000 MFI * ABO-incompatible DD KT * Pregnant or breast-feeding woman * Woman of child-bearing potential, unwilling to use an adequate contraceptive method * Prior participation in clinical trial with (approved or non-approved) IMP within one month prior to screening for this trial. * Prior malignancy diagnosis ≤5 years, except for adequately treated basal cell, or squamous cell skin cancer, and cervical carcinoma in situ * Positive result…