Phase 3
Completed N=517
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
Source: ClinicalTrials.gov NCT00548691 ↗Enrolled (actual)
517
Serious AEs
9.2%
Results posted
May 2015
Primary outcomePrimary: Incidence of Treatment-emergent Serious Adverse Events (SAE's) — 11; 36 participants
Summary
The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Serious Adverse Events (SAE's) |
11; 36 | — |
Eligibility Criteria
Inclusion Criteria
- Male or Female 18 to 85 years of age
- NDD-CKD Patients
- TSAT </= 25%
- Hgb </= 11.5
- Ferritin </= 300
- HD-CKD Patients
- TSAT </= 30%
- Hgb </= 12
- Ferritin </= 500
Exclusion Criteria
- Previous participation in a FCM trial
- Known Hypersensitivity to FCM
- History of anemia other that anemia due to chronic renal failure
- Current history of GI bleeding
- Received IV Iron within the last 30 Days
- Anticipated need for surgery
- Malignancy history
- AST or ALT greater than normal
- Received an investigational drug within 30 days of screening
- Pregnant or sexually active females who are not willing to use an effective form of birth control
Data sourced from ClinicalTrials.gov (NCT00548691). 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.