NCT01900197

Brief Summary

The purpose of this study is to monitor and quality assure the efficacy and safety of Monofer® in a broad patient population when Monofer® is used according to the Monofer® label (SPC) in current practice and where standard routines are being followed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
391

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

2.3 years

First QC Date

July 11, 2013

Last Update Submit

March 1, 2016

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (1)

  • Time to relapse of iron deficiency anemia

    From screening until 12 months

Secondary Outcomes (1)

  • Number of ADRs

    From screening until 12 months

Study Arms (1)

Iron deficiency anemia

Patients with iron deficiency anemia treated on the doctor's discretion with 10% Iron Isomaltoside 1000 (Monofer®) as standard treatment according to current practice

Drug: 10% Iron Isomaltoside 1000

Interventions

10% Iron Isomaltoside 1000DRUG

Administered according to local routines and product labeling in doses at the doctors discretion

Also known as: Monofer®
Iron deficiency anemia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with iron deficiency anemia treated on the doctor's dicretion with Monofer® as standard treatment according to current practice

You may qualify if:

  • Patients with iron deficiency anemia treated on the doctor's discretion with Monofer® as standard treatment according to current practice

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Aalborg, Denmark

Location

Related Publications (1)

  • Frigstad SO, Haaber A, Bajor A, Fallingborg J, Hammarlund P, Bonderup OK, Blom H, Rannem T, Hellstrom PM. The NIMO Scandinavian Study: A Prospective Observational Study of Iron Isomaltoside Treatment in Patients with Iron Deficiency. Gastroenterol Res Pract. 2017;2017:4585164. doi: 10.1155/2017/4585164. Epub 2017 Oct 22.

    PMID: 29213281DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2013

First Posted

July 16, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

DK(1)