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A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI

NCT02182440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2020-03-23

Study results available
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Summary

The purpose of this study is to determine whether recombinant Alkaline Phosphatase (recAP) is effective and save, and to determine the most effective dose, in the treatment of patients with acute kidney injury caused by sepsis.

Conditions

Interventions

BIOLOGICAL

recAP

One hour infusions once daily for three days

OTHER

Placebo

1 hour IV infusion once daily for 3 days

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • AM-Pharma

    lead INDUSTRY

Principal Investigators

  • Jacques Arend, MD DiMD · AM Pharma BV

  • Peter Pickkers, Prof MD. PhD · Department Intensive Care, Radboud University Medical Center

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
2014-12-18
Primary Completion
2017-05-25
Completion
2017-09-27

Countries

  • United States
  • Austria
  • Belgium
  • Czechia
  • Finland
  • France
  • Germany
  • Ireland
  • Netherlands
  • Spain
  • United Kingdom

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 NCT02182440 on ClinicalTrials.gov