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Graft Dysfunction clinical trials

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NCT ID: NCT05031052 Recruiting - Kidney Failure Clinical Trials

Normothermic Machine Perfusion (NMP) Versus Static Cold Storage (SCS) in Human Kidney Transplantation

NMP-DBD
Start date: May 10, 2022
Phase: N/A
Study type: Interventional

Due to organ shortage in kidney transplantation (KT) several strategies have been implemented in an attempt to increase donor pool utilization, including transplantation of extended criteria donor (ECD) allografts. While the transplantation of ECD organs saves patients from waiting-list dropout, these pre-damaged organs exhibit an increased susceptibility to further injury during organ storage and transplantation. Static cold storage (SCS) involves the transportation of procured donor kidneys on ice and has remained the gold standard for organ preservation for decades. SCS relies on hypothermia to reduce cellular metabolism and oxygen demand while achieving a prolonged preservation time of organs. Upon reperfusion, the reintroduction of oxygen to the ischemic kidney leads to a respiratory burst with massive production of mitochondrial reactive oxygen species and subsequent sterile inflammation of the entire organ. This ischemia-reperfusion injury (IRI) is a central predictor of graft and patient survival. Current clinical preservation strategies are unable to meet the challenges of ECD allograft transplantation and there is a great demand to optimize preservation techniques for such high risk ECD allografts. Currently, two main paradigms prevail in the clinical approach to kidney allograft machine perfusion (MP) in regard to optimized preservation techniques: while end-ischemic hypothermic (HMP) and hypothermic oxygenated MP (HOPE) may be seen as dynamic alternatives of the traditional organ preservation based on hypothermia-induced deceleration of metabolism could not proof a beneficial effect on delayed graft function or primary graft failure, the impact of normothermic perfusion (NMP) on ECD kidney allografts is still missing. NMP aims at re-equilibration of cellular metabolism by preserving the organ at physiological temperatures whilst ensuring sufficient oxygen and nutrient supply. The present trial was therefore designed to provide first level-II evidence for NMP in human KT after donation after brain death (DBD). In total, 194 human kidney grafts will be randomized to either 4 hours of NMP directly before implantation (intervention group; n = 97) or to SCS (control group; n = 97) prior to transplantation. The primary endpoint will be kidney function after 6 months (6-months eGFR). Secondary endpoints include kidney function after 3 and 12 months, incidence of delayed graft function (DGF), primary non-function (PNF) and surgical complications assessed by the comprehensive complication index (CCI).

NCT ID: NCT03808324 Recruiting - Clinical trials for Cardiac Allograft Vasculopathy

Heart Failure After Heart Transplantation Due to Chronic Rejection

AVALON
Start date: January 2019
Phase: N/A
Study type: Interventional

This study will investigate the prevalence of allograft vasculopathy and unexplained graft dysfunction during long-term follow-up after heart transplantation. Risk factors as well diagnostic approaches will be investigated.

NCT ID: NCT03786991 Recruiting - Clinical trials for Kidney Transplantation

EPI-STORM: Cytokine Storm in Organ Donors

EPI-STORM
Start date: December 16, 2018
Phase:
Study type: Observational

Kidney and liver transplantation are the treatment of choice and are often the last therapeutic option offered to patients with chronic renal and liver failure. More than 70% of kidneys and liver available for transplantation are obtained from donors following neurological death. Unfortunately, compared to living donation, transplant function, graft survival, and recipient survival are consistently inferior with kidneys and liver from neurologically deceased donors. This difference lies with the exacerbated pro-inflammatory state characteristic of deceased donors. Indeed, when neurologic death occurs, the immune system releases substances in the blood that could harm organs and particularly the liver and the kidneys. We believe that achieving a better understanding of the inflammatory processes of organ donors could be greatly informative to design future randomized controlled trial assessing the effect of personalized immunosuppressive therapy on organ donors to ultimately improve the care provided to donors so as to increase the number of organs available for transplantation and enhancing the survival of received grafts

NCT ID: NCT02826811 Recruiting - Graft Dysfunction Clinical Trials

Role of Anti-BK Virus Neutralizing Antibodies (BKV) as a Prognostic Marker for the Development of Nephropathy BK

Start date: July 2016
Phase: N/A
Study type: Observational

BKV nephropathy (BKV) is one of the most frequent complications of kidney transplantation. In the absence of specific anti-BKV treatment, pre-emptive reduction of immunosuppression is the main strategy that has proven effective in reducing the risk of BKVN. However, it exposes a transplant rejection risk estimated between 4 and 14% according to studies. Despite the pre-emptive reduction of immunosuppression, a significant number of patients continue to progress towards BKVN suggesting that pre-emptive strategy is late. It's therefore urgent to develop new prognostic markers to identify earlier and more effectively patients with a higher risk of developing BKVN.