NCT05743751 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Hamar M, Urbanellis P, Kaths MJ, Kollmann D, Linares I, Ganesh S, Wiebe A, Cen JY, Yip P, John R, Konvalinka A, Mucsi I, Ghanekar A, Bagli D, Grant D, Robinson LA, Selzner M
Normothermic Ex Vivo Kidney Perfusion Reduces Warm Ischemic Injury of Porcine Kidney Grafts Retrieved After Circulatory Death. Transplantation. 2018 Aug;102(8):1262-1270. doi: 10.1097/TP.0000000000002245.
Mazilescu LI, Urbanellis P, Kim SJ, Goto T, Noguchi Y, Konvalinka A, Reichman TW, Sayed BA, Mucsi I, Lee JY, Robinson LA, Ghanekar A, Selzner M
Normothermic Ex Vivo Kidney Perfusion for Human Kidney Transplantation: First North American Results. Transplantation. 2022 Sep 1;106(9):1852-1859. doi: 10.1097/TP.0000000000004098. Epub 2022 Mar 1.
Nicholson ML, Hosgood SA
Renal transplantation after ex vivo normothermic perfusion: the first clinical study. Am J Transplant. 2013 May;13(5):1246-52. doi: 10.1111/ajt.12179. Epub 2013 Feb 22.

Prospective Randomized Controlled Study Normothermic Pulse Perfusion Comparing and Hypothermic Machine Perfusion in Margin Deceased Donor Kidney Transplantation

Details for clinical trial NCT05743751

Clinical trial NCT05743751 - References