Renaparin to improve transplantation outcome for patients with chronic kidney disease
| Reference number | |
| Coordinator | Uppsala universitet - Institutionen för immunologi, genetik och patologi |
| Funding from Vinnova | SEK 1 000 000 |
| Project duration | June 2016 - May 2017 |
| Status | Completed |
Purpose and goal
The aim of the project has been to perform long-term functional evaluation of transplanted kidneys treated with Renaparin with the goal to develop a first class product with a capacity to prevent ischemia reperfusion injuries in kidney transplantation. Described project aims have overall been reached according to the project plan.
Expected results and effects
The capacity of Renaparin to protect the kidney against devastating reperfusion injury has been achieved showing improved kidney function 28 days post transplantation in an experimental model of kidney transplantation in rats. The biodistribution of Renaparin in rodents and liver enzymatic degradation of Renaparin has been performed. CMC and IMPD have been produced and submission of the clinical protocol for the safety study to the Swedish Medical Product Agency (MPA) will occur Q3 2017. CHC/Renaparin has since 2014 acquired Orphan Drug Designation by EMA and also by FDA in 2017
Planned approach and implementation
Kidney transplantation model in rats, long-term study performed Biodistribution study in rodents performed Uptake of Renaparin in endothelial cells performed Metabolism of Renaparin by liver enzymes performed Study of Renaparin binding porcine kidney by the research team in Poitiers performed Evaluation and development of relevant placebo for the safety study performed CMC for the Investigational, Medicinal Product Dossier performed Clinical protocol for the safety study on going Orphan Drug Designation FDA accepted GLP toxicology study in rodents performed