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

D

Dr. Franz Köhler Chemie

Status and phase

Enrolling
Phase 3

Conditions

Kidney Failure
Kidney-Pancreas Failure
Liver Failure, Chronic

Treatments

Drug: Custodiol-N Solution
Drug: Custodiol HTK Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT03627013
CL-N-KLP-TX-III/07-AT/17
2017-002198-20 (EudraCT Number)

Details and patient eligibility

About

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=614 including: Kidney 412 (including approx. 30 combined kidney-pancreas) Liver 202

Enrollment

362 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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 involving compound/interventions aimed at the reduction of preservation and / or ischemia / reperfusion injury)
  • all combined allocations other than pancreas and kidney

Kidney / combined kidney -pancreas recipient

  • double kidney transplantation
  • pancreas retransplantation
  • machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA >0% are only included in the living donation setting.

Liver recipient

  • retransplantation
  • machine perfusion

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

362 participants in 6 patient groups

Kidney Custodiol-N
Experimental group
Treatment:
Drug: Custodiol-N Solution
Kidney Custodiol
Active Comparator group
Treatment:
Drug: Custodiol HTK Solution
Liver Custodiol-N
Experimental group
Treatment:
Drug: Custodiol-N Solution
Liver Custodiol
Active Comparator group
Treatment:
Drug: Custodiol HTK Solution
Kidney/Pancreas Custodiol-N
Experimental group
Treatment:
Drug: Custodiol-N Solution
Kidney/Pancreas Custodiol
Active Comparator group
Treatment:
Drug: Custodiol HTK Solution

Trial contacts and locations

1

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Central trial contact

Astrid Friedel

Data sourced from clinicaltrials.gov

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