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A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects

NCT01602328 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2014-08-06

No results posted yet for this study

Summary

Subjects entering the study will have undergone cardiac surgery. Those who experience kidney injury within 48 hours of their surgery will be enrolled into the study. Once enrolled, subjects will receive a single administration of AC607 or placebo. Kidney recovery will be evaluated over the subsequent 30 days and death or the need for dialysis will be evaluated within 90 days of dosing. After 90 days (evaluation period), subjects will enter a 3-year extension phase of the study to monitor safety and long-term outcomes (follow-up period).

Conditions

Interventions

BIOLOGICAL

AC607

AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight

BIOLOGICAL

Vehicle Only

The dose will be calculated and recorded in the same way as for AC607.

Sponsors & Collaborators

  • AlloCure Inc.

    lead INDUSTRY

Principal Investigators

  • Viken Paragamian

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-06-30
Completion
2014-08-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT01602328 on ClinicalTrials.gov