biostudies-literatureVerbout NGOregon Health and Science UniversityNHLBI NIH HHSU.S. Department of Health &amp; Human Services | NIH | National Heart, Lung, and Blood InstituteOregon Health and Science University (Oregon Health & Science University)U.S. Department of Health & Human Services | NIH | National Heart, Lung, and Blood Institute (NHLBI)153https://www.ebi.ac.uk/biostudies/studies/S-EPMC11282208biostudies-literatureUnknown4(1)<h4>Background</h4>The protein C system regulates blood coagulation, inflammation, and vascular integrity. AB002 is an injectable protein C activating enzyme under investigation to safely prevent and treat thrombosis. In preclinical models, AB002 is antithrombotic, cytoprotective, and anti-inflammatory. Since prophylactic use of heparin is contraindicated during hemodialysis in some end-stage renal disease (ESRD) patients, we propose using AB002 as a short-acting alternative to safely limit blood loss due to clotting in the dialysis circuit.<h4>Methods</h4>This phase 2, randomized, double-blind, placebo-controlled, single-dose study evaluates the safety and tolerability of AB002 administered into the hemodialysis line of ESRD patients during hemodialysis at one study center in the United SCommunications medicineSafety and tolerability of the protein C activator AB002 in end-stage renal disease patients on hemodialysis: a randomized phase 2 trial.PMC11282208HL147695R01 HL049413R01 HL147821HL139554R01 HL139554HL147821R44 HL147695Elemental Analysis CoreLorentz CUGruber AMarkway BDWallisch MMarbury TCShatzel JJDi Cera EVerbout NGTucker EIfalseSafety and tolerability of the protein C activator AB002 in end-stage renal disease patients on hemodialysis: a randomized phase 2 trial.<h4>Background</h4>The protein C system regulates blood coagulation, inflammation, and vascular integrity. AB002 is an injectable protein C activating enzyme under investigation to safely prevent and treat thrombosis. In preclinical models, AB002 is antithrombotic, cytoprotective, and anti-inflammatory. Since prophylactic use of heparin is contraindicated during hemodialysis in some end-stage renal disease (ESRD) patients, we propose using AB002 as a short-acting alternative to safely limit blood loss due to clotting in the dialysis circuit.<h4>Methods</h4>This phase 2, randomized, double-blind, placebo-controlled, single-dose study evaluates the safety and tolerability of AB002 administered into the hemodialysis line of ESRD patients during hemodialysis at one study center in the United S2024-01-01T00:00:00Z2024 Jul2026-06-01T06:51:35.782Z2025-04-19T13:09:45.899ZS-EPMC112822083906037010.1038/s43856-024-00575-y