A Prospective, Randomized, Single Blind, Multicentre Phase III Study on Organ Preservation With Custodiol-N Solution Compared With Custodiol Solution in Or-gan Transplantation (Kidney, Liver and Pancreas)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas) Protocol number: CL-N-KLP-TX-III/07-AT/17 Trial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver. Intended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days). Purpose of the study The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas. Patient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study. Planned number of patients (recipients) In total N=362 including: Kidney 242 (including approx. 30 combined kidney-pancreas) Liver 120

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University Graz
RECRUITING
Graz
Medical University Innsbruck
RECRUITING
Innsbruck
Ordensklinikum Linz
RECRUITING
Linz
Medical University Vienna
RECRUITING
Vienna
Contact Information
Primary
Astrid Friedel
astrid.friedel@medunigraz.at
+4332638578017
Time Frame
Start Date: 2019-05-23
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 362
Treatments
Experimental: Kidney Custodiol-N
Active_comparator: Kidney Custodiol
Experimental: Liver Custodiol-N
Active_comparator: Liver Custodiol
Experimental: Kidney/Pancreas Custodiol-N
Active_comparator: Kidney/Pancreas Custodiol
Sponsors
Leads: Dr. F. Köhler Chemie GmbH

This content was sourced from clinicaltrials.gov