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Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury

NCT03403751 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2021-10-12

Study results available
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Summary

Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

Conditions

Interventions

DRUG

Reltecimod 0.5 mg/kg

Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes

DRUG

Placebo

Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes

Sponsors & Collaborators

  • Atox Bio Ltd

    lead INDUSTRY

Principal Investigators

  • Azra Bihorac, MD · University of Florida Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2019-12-14
Completion
2019-12-14
FDA Drug
Yes

Countries

  • United States
  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03403751 on ClinicalTrials.gov