Pharmacosmos A/S
🇩🇰Denmark
Iron Isomaltoside 1000 (Monofer®) Administered by a High Dosing Regimen in Subjects With Inflammatory Bowel Disease
- 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
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: 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)
- 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
- 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 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 1000Drug: 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 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 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 AnaemiaNon-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
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