WHO ICTRP trial

A Clinical study to assess PK properties of iron isomaltoside 1000 (Monofer®)…

CTRI/2012/01/002319 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2012/01/002319
Public title A Clinical study to assess PK properties of iron isomaltoside 1000 (Monofer®) administered by 500 mg IV bolus injection or 1000 mg intravenous infusion to patients with Non-Dialysis Dependent Chronic Kidney Disease
Scientific title A 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-Dialysis Dependent Chronic Kidney Disease - none
Primary sponsor Pharmacosmos AS
Secondary sponsors Max Neeman International
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 3
Countries India
Conditions Health Condition 1: null- Non-Dialysis Dependent Chronic Kidney Disease (CKD)
Interventions Intervention1: Iron isomaltoside 1000 (Monofer®): administered as 500 mg IV bolus injections Frequency: Once Daily Duration: Once in the Study Intervention2: Iron isomaltoside 1000 (Monofer®): administered as 1000 mg IV infusions…
Registration date Mar 1, 2012
Target size 16
Secondary IDs P-Monofer-PK-CKD-03
Registry page ctri.nic.in

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