Идёт набор NCT03627013

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

Фаза III С лечением Kidney Failure Liver Failure, Chronic Kidney-Pancreas Failure

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Custodiol-N Solution, Custodiol HTK Solution.
Кому может быть актуально: Состояния в реестре: Kidney Failure, Liver Failure, Chronic, Kidney-Pancreas Failure. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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

Вмешательства

Препарат Custodiol-N Solution
Perfusion
Препарат Custodiol HTK Solution
Perfusion

Первичные конечные точки

Kidney: - delayed graft function: Dialysis requirement during the first week af-ter transplantation [Срок оценки: 7 days]
Liver: - area under the curve (AUC) GPT (ALT) after transplantation during 7 days (minimum 1 measurement per day) [Срок оценки: 7 days]

Критерии участия

Критерии включения

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

Критерии исключения

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