Trials / Completed
CompletedNCT01469078
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)
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) (PK-CKD-05)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Pharmacosmos A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Monofer® | Single Bolus Injections |
Timeline
- Start date
- 2011-10-01
- Primary completion
- 2012-04-01
- Completion
- 2012-11-01
- First posted
- 2011-11-10
- Last updated
- 2012-11-08
Source: ClinicalTrials.gov record NCT01469078. Inclusion in this directory is not an endorsement.