The ischemia reperfusion injury challenge in kidney transplantation
Donor kidneys lack natural blood flow while awaiting transplantation. This can lead to ischemia (a shortage of oxygen supply to the kidney tissue). When connected to the recipient’s blood flow, this in turn leads to ischemia reperfusion injury (IRI) and delayed graft function, a problem in up to 40 % of all kidney transplantations. Given the alarming shortage of organs available for transplantation in the EU and internationally, the prevention of IRI has become a top priority for the transplantation community.
Project objectives and time frame
Corline has previously shown in preclinical studies that Renaparin® has the potential to decrease IRI in association with kidney transplantation. Through the Phase I/IIa clinical trial in humans, the intent is to demonstrate Renaparin’s® potential to improve the number of successful kidney transplantations. The produced clinical safety data will constitute the basis for further clinical development and commercialisation of the product. Specific project objectives are:
- To demonstrate (in a Phase I/IIa clinical trial) that Renaparin® is safe for its intended use
- To explore ways of clinically showing that Renaparin® has the potential to improve transplantation outcome by attenuating ischemia reperfusion injury
- To produce data on user experience and to identify potential opportunities for optimization in regard to drug administration, formulation, packaging and handling
The activities proposed in this project will bring Renaparin® through a Phase I/IIa clinical trial in humans during the 24 months project time, and prepare further development into Phase IIb/III trials.
Long term, Corline’s strategic focus lies on establishing Renaparin® as a new cell replacement technology in kidney transplantation. The Horizon 2020 project will constitute the cornerstone of Corline’s accelerated growth and the project is the key step to realize this strategy.
