dm+d

Unassigned

New Medicines

Vascular access for haemodialysis in end-stage renal disease

Information

New molecular entity
Humacyte
Humacyte

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials
Mar 17Granted Regenerative Medicine Advanced Therapy for vascular access for haemodialysis by the FDA [1].

Category

A bio-engineered vascular tube, utilising human vascular cells to form a mechanically strong, engineered tube similar to native blood vessels
In England, each year about 5,800 people start treatment for kidney failure and about four in 10 are treated with haemodialysis while one in 10 is treated with peritoneal dialysis. Around 30,000 patients are on dialysis [1].
Vascular access for haemodialysis in end-stage renal disease
Implantation

Trial or other data

Oct 20PIII study (NCT03183245) continues to recruit at sites in the US. Collection of primary outcome data is now expected to finish in Sep 21. PIII HUMANITY study is ongoing and due to complete primary outcome data collection in Sep 22 [3].
Oct 19PIII HUMANITY study is no longer recruiting [2].
Jun 19PIII study (NCT03183245) is recruiting [2].
Sep 17PIII study (NCT03183245) to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access starts. 240 adults will be recruited in the US. Collection of primary outcome data (proportion of subjects with functional patency at 6 months post study access (SA) creation, and proportion of subjects with secondary patency of SA at 12 months post SA creation) is due to complete Dec 19 [2].
May 16PIII HUMANITY study to compare the HAV with ePTFE grafts when used for hemodialysis access starts (NCT02644941). 355 adults will be recruited in the US, Germany, Israel, Poland, Portugal and the UK. Primary outcome is time to loss of secondary patency from implantation; collection of these data is due to complete Sep 22 [2].

Evidence based evaluations