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Preventing Systemic Inflammation After Cardiac Surgery With Alkaline Phosphatase

NCT03050476 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2024-04-19

No results posted yet for this study

Summary

Study should demonstrate that alkaline phosphatase reduces the incidence and extent of acute kidney injury after cardiopulmonary bypass (CPB) as defined by the AKIN criteria.

Conditions

  • Systemic Inflammation
  • Cardiopulmonary-bypass

Interventions

DRUG

RESCAP®

intravenous application before, during, and for 24 or 96 hours after heart surgery

DRUG

placebo

intravenous application before, during, and for 24 or 96 hours after heart surgery

Sponsors & Collaborators

  • Aix Scientifics

    collaborator INDUSTRY

  • Alloksys Life Sciences B.V.

    lead INDUSTRY

Principal Investigators

  • Ruud Brands, PhD · Alloksys Life Sciences BV . President

  • Dominik Wiedemann, Prof.Dr. · Universitätsklinikum St. Pölten, Austria

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2025-09-30
Completion
2026-03-31

Countries

  • Australia
  • Austria
  • Belgium
  • Germany
  • Italy
  • Malaysia
  • Netherlands
  • Portugal
  • Russia
  • Singapore
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT03050476 on ClinicalTrials.gov