DeepMed Research

Iron isomaltoside 1000

Generic Name: Iron isomaltoside 1000

Drug Type: Small Molecule

CAS Number: 1370654-58-2

Unique Ingredient Identifier: 3M6325NY1R

Background: Iron isomaltoside 1000 is under investigation in Iron Deficiency Anaemia. Iron isomaltoside 1000 has been investigated for the treatment and basic science of Anemia, Gastric Cancer, Esophageal Cancer, Chronic Kidney Disease, and Anemia, Iron-Deficiency, among others.

Associated Conditions: Iron Deficiency (ID), Iron Deficiency Anemia (IDA)

Clinical Trials

Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia

Not Applicable

Completed

Conditions: Postpartum Anemia

Interventions: Drug: Iron isomaltoside 1000
Drug: Ferrous sulphate

First Posted Date: 2012-06-27

Last Posted Date: 2016-08-03

Lead Sponsor: Dow University of Health Sciences

Target Recruit Count: 271

Registration Number: NCT01628770

Locations: 🇵🇰
Dow University of Health Sciences, Karachi, Sindh, Pakistan

Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease

Phase 3

Completed

Conditions: Inflammatory Bowel Disease

Interventions: Drug: Iron Isomaltoside 1000

First Posted Date: 2012-05-16

Last Posted Date: 2015-04-29

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 21

Registration Number: NCT01599702

Locations: 🇩🇰
Pharmacosmos A/S, Hoelbaek, Denmark

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

Phase 1

Completed

Conditions: Chronic Kidney Disease

Interventions: Drug: Monofer®

First Posted Date: 2011-11-10

Last Posted Date: 2012-11-08

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 18

Registration Number: NCT01469078

Safety and Efficacy Extension Study of Iron Isomaltoside 1000 (Monofer®) in Subjects With Inflammatory Bowel Disease

Phase 3

Completed

Conditions: Anaemia
Inflammatory Bowel Disease

Interventions: Drug: Monofer

First Posted Date: 2011-08-05

Last Posted Date: 2013-11-26

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 39

Registration Number: NCT01410435

Locations: 🇭🇺
Hungary, Hungary, Hungary
🇦🇹
Austria, Austria, Austria

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

Phase 3

Completed

Conditions: Chronic Kidney Disease Stage 5 (Dialysis Dependent)

Interventions: Drug: Iron sucrose
Drug: Monofer

First Posted Date: 2010-10-18

Last Posted Date: 2015-12-02

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 351

Registration Number: NCT01222884

Locations: 🇮🇳
Jatin Kothari, Mumbai, India

Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

Phase 1

Completed

Conditions: Inflammatory Bowel Disease

Interventions: Drug: Monofer (iron isomaltoside 1000)
Drug: Monofer

First Posted Date: 2010-10-04

Last Posted Date: 2013-11-14

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 16

Registration Number: NCT01213680

Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD

Phase 1

Completed

Conditions: Non-dialysis Dependent Chronic Kidney Disease

Interventions: Drug: Iron isomaltoside 1000

First Posted Date: 2010-10-04

Last Posted Date: 2013-11-14

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 16

Registration Number: NCT01213992

A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Phase 3

Completed

Conditions: Chemotherapy Induced Anaemia
Non-myeloid Malignancies

Interventions: Drug: iron isomaltoside 1000
Drug: iron sulphate

First Posted Date: 2010-06-16

Last Posted Date: 2015-12-03

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 350

Registration Number: NCT01145638

Locations: 🇮🇳
Apollo Hospitals, New Delhi, India

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

Phase 3

Completed

Conditions: Iron Deficiency Anemia
Chronic Kidney Disease

Interventions: Drug: Iron Sulphate
Drug: Monofer

First Posted Date: 2010-04-13

Last Posted Date: 2015-12-03

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 351

Registration Number: NCT01102413

Locations: 🇩🇰
Pharmacosmos, Holbaek, Denmark

Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

Phase 3

Completed

Conditions: Inflammatory Bowel Disease

Interventions: Drug: Iron Sulphate
Drug: Monofer

First Posted Date: 2009-11-20

Last Posted Date: 2012-11-27

Lead Sponsor: Pharmacosmos A/S

Target Recruit Count: 350

Registration Number: NCT01017614

Locations: 🇬🇧
Research Site, London, United Kingdom

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