A Prospective, randomized, single blind, multicentre Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in organ transplantation (kidney, liver and pancreas)

Phase 1

• Conditions: patients who will undergo kidney, liver or kidney-pancreatic transplantation; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2017-002198-20-AT
• Lead Sponsor: Dr. Franz Köhler Chemie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

All organs (kidney, combined kidney – pancreas and liver)

Donor criteria
-For All patients undergoing deceased donation:
-deceased adult (=18 years) donors fulfilling the criteria for organ donation
-For All patients undergoing living kidney donation:
-adult (=18 years) living kidney donors fulfilling the criteria for organ donation
-
-
Patient (recipient) criteria
-recipients awaiting their transplant
-recipients =18 years
-recipients’ signed informed consent before the transplantation

Kidney / combined kidney - pancreas recipients
-n/a
Liver recipient
-full organ transplantation

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 272
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

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
-general refusal of organ donation
-donation after cardiac death (DCD)

Patient (recipient) criteria
-pregnant or lactating patients
-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)
-all combined allocations other than pancreas and kidney

Kidney / combined kidney -pancreas recipient
-double kidney transplantation
-pancreas re-transplantation
-machine perfusion

According to the KDIGO-Guidelines (2009) all patients with PRA >0% are only included in the living donation setting.

Liver recipient
-re-transplantation
-machine perfusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified