MedPath

Pharmacosmos A/S

🇩🇰Denmark
Ownership
Subsidiary
Employees
-
Market Cap
-
Website
http://www.pharmacosmos.com

A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof

Phase 3
Completed
Conditions
Non-anaemic Patients Undergoing Cardiac Surgery
Interventions
Drug: Iron isomaltoside 1000 (Monofer®)
Drug: Natriumklorid 9 mg/ml, Fresenius Kabi
First Posted Date
2012-03-27
Last Posted Date
2014-04-29
Lead Sponsor
Pharmacosmos A/S
Target Recruit Count
74
Registration Number
NCT01563367

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
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
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

Pharmacokinetic Study of Iron Isomaltoside 1000 Administered by 250 mg IV Bolus Injection or 500 mg Intravenous Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia

Phase 1
Completed
Conditions
Patients With Chemotherapy Induced Anemia (CIA)
Interventions
Drug: Monofer(R)
First Posted Date
2011-01-20
Last Posted Date
2013-06-04
Lead Sponsor
Pharmacosmos A/S
Target Recruit Count
11
Registration Number
NCT01280240
Locations
🇺🇸

Gabrail Cancer Center, Canton, Ohio, United States

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
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
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 Infusion to Patients With Non-hematological Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

Phase 1
Completed
Conditions
Non-hematological Malignancies
Interventions
Drug: 1000 mg iron isomaltoside 1000
Drug: 500 mg iron isomaltoside 1000
First Posted Date
2010-10-04
Last Posted Date
2013-06-27
Lead Sponsor
Pharmacosmos A/S
Target Recruit Count
16
Registration Number
NCT01213979

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
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
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
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

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