Trial intelligence / Profile preview

Custodiol-N versus Custodiol for organ preservation in kidney, liver, and kidney-pancreas transplantation

2024-512444-29-00Phase 3Authorised

Sponsor
Franz Köhler Chemie
Start
May 2019
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Small Molecules
Countries
1
01

Overview

Phase 3, randomised, single-blind trial in end-stage kidney disease (ESKD), hepatic disease and diabetes mellitus type 1 (T1D) comparing Custodiol-N preservation with Custodiol preservation (2 arms). Primary endpoints: Delayed graft function and AUC of GPT (ALT) over first 7 days. Planned start May 2019; status: authorised.

02

Drugs

histidine-tryptophan-ketoglutarate solution (modified)HTK Custodiol
03

Conditions

end-stage kidney disease (ESKD)hepatic diseasediabetes mellitus type 1 (T1D)

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