drugset / Trial / NCT00317239
VIT45 Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
Timeline
- Start
- 2005-05
- Primary completion
- 2007-02
- Completion
- 2007-08
Outcome
Met primary endpoint
paper 60.4% with ferric carboxymaltose and 34.7% with oral iron (P < 0.001). PMID 20929915 ↗
Publications
- Results Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant. 2011 May;26(5):1599-607. doi: 10.1093/ndt/gfq613. Epub 2010 Oct 7.
- Results Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ferric carboxymaltose | Other / unclassified | 500 mg | Intravenous |
| Subject | Ferric carboxymaltose | Other / unclassified | 1000 mg | Intravenous |
| Comparator | Ferrous Sulfate | Diagnostic / imaging agent | 325 mg | Oral |