BridgeMD
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)
EU CTIS ID: 2024-512444-29-00
What this study is testing
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 kidney-pancreas.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Donor criteria - For All patients undergoing deceased donation: - deceased adult (≥18 years) donors fulfilling the criteria for organ donation
- donor criteria - For All patients undergoing living kidney donation: - adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
- - recipients awaiting their transplant
- - recipients ≥18 years
- - recipients' signed informed consent before the transplantation
- Liver recipient - full organ transplantation
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
- - 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
- - general refusal of organ donation
- - pregnant or lactating patients
See the full eligibility criteria
- Donor criteria - For All patients undergoing deceased donation: - deceased adult (≥18 years) donors fulfilling the criteria for organ donation
- donor criteria - For All patients undergoing living kidney donation: - adult (≥18 years) living kidney donors fulfilling the criteria for organ donation
- - recipients awaiting their transplant
- - recipients ≥18 years
- - recipients' signed informed consent before the transplantation
- 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
- - 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
- - general refusal of organ donation
- - 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
- double kidney transplantation
- - pancreas re-transplantation
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.