MedTrace Logo

Ilofotase Alfa for Prevention of Renal Damage After Cardiac Surgery

NCT06168799 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2025-12-15

No results posted yet for this study

Summary

The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.

Conditions

  • Open Heart Surgery

Interventions

DRUG

Ilofotase alfa

After dilution of the concentrate, the investigational medicinal product will be administered by intravenous infusion for 1 hour at the same day before and after the surgery (Day 1)

DRUG

Placebo

After dilution of the concentrate, the investigational medicinal product will be administered by intravenous infusion for 1 hour at the same day before and after the surgery (Day 1)

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • AM-Pharma

    lead INDUSTRY

Principal Investigators

  • Pickkers, Prof, MD, PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2025-10-05
Completion
2025-12-03
FDA Drug
Yes

Countries

  • Germany

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 NCT06168799 on ClinicalTrials.gov