MedTrace Logo

A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

NCT01222884 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2015-12-02

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).

Conditions

  • Chronic Kidney Disease Stage 5 (Dialysis Dependent)

Interventions

DRUG

Monofer

Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

DRUG

Iron sucrose

Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Sponsors & Collaborators

  • Pharmacosmos A/S

    lead INDUSTRY

Principal Investigators

  • Lars Lykke Thomsen, MD · Pharmacosmos A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-10-31
Completion
2013-12-31

Countries

  • India

Study Locations

More Related Trials

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 NCT01222884 on ClinicalTrials.gov