NCT03612856

Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy/Potency of a Single Dose of Xisomab 3G3, Administered at the Beginning of a Regular Hemodialysis Procedure, in Patients With End-Stage Renal Disease on Chronic Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Aronora, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB023 (xisomab 3G3) or placebo (at a ratio of 2:1 active: placebo).

Conditions

• End Stage Renal Disease
• Thrombosis

Interventions

Type	Name	Description
DRUG	AB023- Dose 1	Participants will receive a single dose of 0.25 mg/kg AB023.
DRUG	AB023-Dose 2	Participants will receive a single dose of 0.5 mg/kg AB023.
DRUG	placebo	Participants will receive a single dose of placebo.

Timeline

• Start date: 2018-10-29
• Primary completion: 2019-07-06
• Completion: 2019-07-06
• First posted: 2018-08-02
• Last updated: 2024-03-07
• Results posted: 2020-07-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study