Anemia Clinical Trial
— FIRSTOfficial 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
| Verified date | July 2023 |
| Source | AMAG Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).
| Status | Completed |
| Enrollment | 162 |
| Est. completion date | April 19, 2012 |
| Est. primary completion date | July 19, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: Key Inclusion Criteria include: 1. Males and females =18 years of age 2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis) 3. Hemoglobin <11.0 g/deciliter (dL) 4. Transferrin saturation <30% 5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week 6. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study Exclusion Criteria: Key Exclusion Criteria include: 1. History of allergy to IV iron 2. Allergy to 2 or more classes of drugs 3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 4. Hemoglobin =7.0 g/dL 5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period 6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency) |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Antwerpen | |
| Belgium | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Antwerpen | |
| Canada | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montréal | Quebec |
| Canada | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Montréal | Quebec |
| Canada | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Richmond Hill | Ontario |
| Canada | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Vancouver | British Columbia |
| Germany | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Berlin | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Düsseldorf | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Göttingen | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Munich | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nürnberg | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Passau | |
| India | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bangalore | |
| India | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nagpur | |
| India | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Pune | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Katowice | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lódz | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Opole | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Radom | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Szczecin | |
| Poland | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Warszawa | |
| United Kingdom | For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | London | |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Augusta | Georgia |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bethesda | Maryland |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Bethlehem | Pennsylvania |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Chula Vista | California |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Evergreen Park | Illinois |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Flushing | New York |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Meridian | Idaho |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mountain View | California |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Rosedale | New York |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | San Antonio | Texas |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Shreveport | Louisiana |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Springfield | Massachusetts |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Tempe | Arizona |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-411-2510 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Whittier | California |
| Lead Sponsor | Collaborator |
|---|---|
| AMAG Pharmaceuticals, Inc. |
United States, Belgium, Canada, Germany, India, Poland, United Kingdom,
Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712. — View Citation
Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Change In Hemoglobin From Baseline (Day 1) To 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. |
Baseline (Day 1), Week 5 | |
| Primary | Percentage Of Participants With An Increase In Hemoglobin =1.0 g/dL From Day 1 (Baseline) 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). | Baseline (Day 1) and up to Week 5 |
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