CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
AB023- Dose 1 +2 moredrug
Likely dose
AB023- Dose 1 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03612856
NCT03612856Phase 2Completed
CompareCT.gov

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

Aronora, Inc.·interventional·Posted Aug 2, 2018·Updated Mar 7, 2024

In Brief

A Phase 2 clinical trial evaluating AB023- Dose 1, AB023-Dose 2, and 1 other intervention for End Stage Renal Disease and Thrombosis. Completed, enrolled 27 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Thrombosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 2, 2018
Enrollment StartOct 29, 2018
Primary CompletionJul 6, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.9 years ago

Interventions

AB023- Dose 1drug

Participants will receive a single dose of 0.25 mg/kg AB023.

AB023-Dose 2drug

Participants will receive a single dose of 0.5 mg/kg AB023.

placebodrug

Participants will receive a single dose of placebo.