CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 502 enrolled
Drug / intervention
darbepoetin alfa +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00661999
NCT00661999Phase 3Completed

A Phase III, Randomized Study of the Effects of Parenteral Iron, Oral Iron, or No Iron Supplementation on the Erythropoietic Response to Darbepoetin Alfa for Cancer Patients With Chemotherapy-Associated Anemia

Mayo Clinic·interventional·Posted Apr 21, 2008·Updated May 17, 2011

In Brief

A Phase 3 clinical trial evaluating darbepoetin alfa, ferrous sulfate, and 2 other interventions for Anemia and 6 related conditions. Completed, enrolled 502 participants across 2 sites.

Detailed Summary

RATIONALE: Darbepoetin alfa may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known whether giving darbepoetin alfa (DA) together with intravenous iron or oral iron is more effective than giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy. PURPOSE: This randomized phase III trial is studying giving darbepoetin alfa together with iron to see how well it works compared with giving darbepoetin alfa together with a placebo in treating anemia caused by chemotherapy in patients with cancer.

Study Details

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 21, 2008
Enrollment StartJan 1, 2006
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 18.2 years ago

Interventions

darbepoetin alfabiological

Given by injection

ferrous sulfatedietary

Given by mouth

sodium ferric gluconate complex in sucrosedrug

Given by IV

placeboother

Given by mouth