Phase III Study Comparing Custodiol-N and Custodiol Solutions for Preserving Kidneys, Liver, and Pancreas in Organ Transplantation

What this Trial Is About

Researchers are conducting a prospective, randomized, single blind, multicenter phase III study comparing two organ preservation solutions, Custodiol-N and Custodiol, in transplantation of the kidney, liver, and combined kidney-pancreas. The goal is to show that Custodiol-N is not inferior to Custodiol in preserving graft function and reducing injury after transplantation. This study includes patients of all genders undergoing these organ transplants. Participants will receive organ preservation treatment using either Custodiol-N solution or Custodiol HTK solution during transplantation of kidney, liver, or combined kidney-pancreas. The trial includes separate groups for each organ type, each randomized to one of the two preservation solutions. The overall study duration per participant is about 3 months, covering transplantation and a 90-day follow-up period. During the study, researchers will monitor outcomes such as delayed graft function in kidney recipients, defined by the need for dialysis in the first week after transplantation, and liver enzyme levels ALT in liver recipients over the first 7 days. Patients will be followed for 90 days post-transplant to assess graft function and injury. The study involves regular clinical assessments and data collection to compare the effects of the two solutions on transplant success and safety.

Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)