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Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

NCT01102413 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2015-12-03

Study results available
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Summary

The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).

Conditions

Interventions

DRUG

Monofer

Infusion or injections

DRUG

Iron Sulphate

Oral intake

Sponsors & Collaborators

  • Pharmacosmos A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Denmark

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 NCT01102413 on ClinicalTrials.gov