NCT02546154

Brief Summary

The objective is to monitor and quality assure the efficacy, including effects on quality of life, and safety of Monofer® in Chronic Kidney Disease and Inflammatory Bowel Disease patient populations when Monofer® is used according to the Monofer® label (Summary of Product Characteristics, SPC) in current clinical 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
359

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

September 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 22, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 23, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

September 8, 2015

Last Update Submit

May 22, 2019

Conditions

Iron Deficiency Anaemia

Keywords

IronAnaemiaAnaemia, Iron-DeficiencyKidney DiseasesInflammatory Bowel DiseasesFatigue

Outcome Measures

Primary Outcomes (1)

  • Time to relapse of iron deficiency anaemia

    From screening until 12 months

Secondary Outcomes (4)

  • Change in scores for fatigue symptoms

    Immediately before to earliest 4 weeks after each treatment course during 12 months

  • Change in anaemia-related blood parameter levels (haemoglobin, iron parameters)

    Immediately before to earliest 4 weeks after each treatment course during 12 months

  • IV iron dose (total needed dose per treatment course)

    From screening until 12 months

  • Number and seriousness of Adverse Drug Reactions

    From screening until 12 months

Study Arms (2)

CKD, iron deficiency anaemia

10% Iron Isomaltoside 1000 administered intravenously to Chronic Kidney Disease patients in doses at the doctor's discretion for treatment of iron deficiency anaemia.

Drug: 10% Iron Isomaltoside 1000

IBD, iron deficiency anaemia

10% Iron Isomaltoside 1000 administered intravenously to Inflammatory Bowel Disease patients in doses at the doctor's discretion for treatment of iron deficiency anaemia.

Drug: 10% Iron Isomaltoside 1000

Interventions

10% Iron Isomaltoside 1000DRUG

Standard clinical practice and following the Monofer® label (SPC)

Also known as: Monofer®
CKD, iron deficiency anaemiaIBD, iron deficiency anaemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients ≥18 years of age diagnosed with iron deficiency anaemia as a consequence of CKD or IBD.

You may qualify if:

  • Patients diagnosed with iron deficiency anaemia as a consequence of CKD or IBD (on the basis of local definition or clinical judgement), treated on the doctor's discretion with Monofer® as standard treatment according to current practice

You may not qualify if:

  • Patients diagnosed with both CKD and IBD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Devon and Exeter Hospital NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

Related Publications (1)

  • Kalra PA, Bhandari S, Spyridon M, Davison R, Lawman S, Mikhail A, Reaich D, Pritchard N, McCafferty K, Moore J. NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease. BMC Nephrol. 2020 Dec 10;21(1):539. doi: 10.1186/s12882-020-02180-2.

    PMID: 33302891DERIVED

MeSH Terms

Conditions

Anemia, Iron-DeficiencyAnemiaKidney DiseasesInflammatory Bowel DiseasesFatigue

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sylvia Simon, PhD

    Pharmacosmos A/S

    STUDY CHAIR

  • Jason Moore, BMedSci, BMBS, FRCP

    Royal Devon and Exeter Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 10, 2015

Study Start

January 22, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 23, 2019

Record last verified: 2019-03

Locations

GB(1)