Phase 3
Completed N=127
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease
Source: ClinicalTrials.gov NCT00317226 ↗Enrolled (actual)
127
Serious AEs
18.1%
Results posted
Jun 2015
Primary outcomePrimary: Incidence of Treatment-emergent Adverse Events — 84 each event
Summary
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events |
84 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who completed or discontinued Protocol 1VIT04004
Exclusion Criteria
- Known hypersensitivity reaction to VIT-45
- Anemia not related to CKD
- Chronic, serious infection
- Recent IV iron other than study drug in past 12 weeks
- Recent blood loss within the last 12 weeks
- Need for surgery or dialysis
- Female subjects who are pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00317226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.