Phase 3 N=182 Randomized Treatment

Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia

Anemia

Bottom Line

View on ClinicalTrials.gov: NCT00236977 ↗

Enrolled (actual)

182

Serious AEs

8.8%

Results posted

Mar 2010

Primary outcome: Primary: Patients With an Increase in Hemoglobin >= 1gm/dL. — 35; 23 participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Venofer (Drug); Ferrous Sulfate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: American Regent, Inc.
Primary completion: Oct 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Patients With an Increase in Hemoglobin >= 1gm/dL.	35; 23	—
SECONDARY Number of Subjects With a Clinical Response	31; 1	—
SECONDARY Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56	1.1; .8	—
SECONDARY Highest Change From Baseline in Ferritin (ng/mL) up to Day 56	391.7; 45	—
SECONDARY Mean Change in Ferritin (ng/mL) From Baseline to Day 56	230; 30	—
SECONDARY Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56	8.5; 5.5	—
SECONDARY Mean Change From Baseline in Hemoglobin (g/dL) at Day 56	.7; .3	—

Summary

To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.

Eligibility Criteria

Inclusion Criteria

Hemoglobin < or = 11.5 gm/dL
Stable dose or not receiving EPO
Renal Anemia

Exclusion Criteria

IV iron with last 6 months
Chronic infection, malignancy,major surgery within last month
Blood Transfusion with last two months
Significant blood loss within last 3 months
Concomitant sever diseases of the liver

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Data sourced from ClinicalTrials.gov (NCT00236977). 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.