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Compares treatment options for Kidney Failure
Official title Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)
ClinicalTrials.gov ID: NCT03627013
What this study is testing
What is Custodiol-N Solution?
Custodiol-N Solution is an investigational medicine, being studied as a potential treatment for kidney failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All organs (kidney, combined kidney - pancreas and liver) Donor criteria For All patients undergoing deceased donation: \- deceased adult (≥18 years)...
- recipients awaiting their transplant
- recipients ≥18 years
- recipients' signed informed consent before the transplantation Kidney / combined kidney - pancreas recipients
- n/a Liver recipient
You likely can't join if
- 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 treatment study (e.g. another study involving compound/interventions aimed at the reduction of preservation and / or...
See the full eligibility 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...
- 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
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
- Innsbruck, Austria
- Linz, Austria
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria; Innsbruck, Austria; Linz, Austria; Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.