A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease (FIRST)
|ClinicalTrials.gov Identifier: NCT01052779|
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anemia Kidney Disease||Drug: Ferumoxytol Drug: Iron Sucrose||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease|
|Actual Study Start Date :||March 1, 2010|
|Actual Primary Completion Date :||July 19, 2011|
|Actual Study Completion Date :||April 19, 2012|
Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
Other Name: Feraheme
Active Comparator: Iron Sucrose
Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.
Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.
Drug: Iron Sucrose
IV Iron Sucrose
Other Name: Venofer
- Mean Change In Hemoglobin From Baseline (Day 1) To Week 5 [ Time Frame: Baseline (Day 1), Week 5 ]
The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:
Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)
The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.
- Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5 [ Time Frame: Baseline (Day 1) and up to Week 5 ]The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01052779
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