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The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol | Experimental | Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g). |
|
| Iron Sucrose | Active Comparator | Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol | Drug | IV Ferumoxytol |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only. | Baseline (Day 1) through Week 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change In Hemoglobin From Baseline To Week 5 | Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. |
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Key Inclusion Criteria include:
Males and females ≥18 years of age
Participants with IDA defined as having:
Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
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 participation in the study
Key Exclusion Criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Adelaide | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27462400 | Background | 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. | |
| 24639149 | Background |
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The study was open to enrollment for adult participants with iron deficiency anemia (IDA), defined as hemoglobin <10.0 grams (g)/deciliter (dL) and transferrin saturation (TSAT) <20%, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferumoxytol | Participants received a total of 2 doses of intravenous (IV) ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Iron Sucrose | Drug | IV Iron Sucrose |
|
|
| Baseline (Day 1), Week 5 |
| Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5 | Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders. | Baseline (Day 1) through Week 5 |
| Mean Change In TSAT From Baseline To Week 5 | Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero. | Baseline (Day 1), Week 5 |
| Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5 | The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero. | Baseline (Day 1), Week 5 |
| Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline | The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included. | From Baseline (Day 1) up to Week 5 |
| 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. | Ballarat | Australia |
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| 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. | Cambridge | United Kingdom |
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| 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. |
| Iron Sucrose |
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED | Completed is defined as had study drug and Week 5 visit. |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ferumoxytol | Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g. |
| BG001 | Iron Sucrose | Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 | Participants who achieved a ≥2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a ≥2.0 g/dL increase. Statistical analysis was performed for data up to Week 5 only. | ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment. | Posted | Count of Participants | Participants | Baseline (Day 1) through Week 5 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change In Hemoglobin From Baseline To Week 5 | Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. | ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment. | Posted | Mean | Standard Deviation | g/dL | Baseline (Day 1), Week 5 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5 | Participants who achieved a ≥12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders. | ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment. | Posted | Count of Participants | Participants | Baseline (Day 1) through Week 5 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change In TSAT From Baseline To Week 5 | Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero. | ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment. | Posted | Mean | Standard Deviation | percentage of saturation | Baseline (Day 1), Week 5 |
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| Secondary | Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5 | The FACIT-Fatigue questionnaire is a 13 item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue. Mean change in FACIT-Fatigue Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline). Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero. | ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 1), Week 5 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline | The time to hemoglobin increase of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of ≥2.0 g/dL or hemoglobin value of ≥12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of ≥2.0 g/dL or to a hemoglobin level ≥12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included. | ITT Population: Any randomized participant who had any exposure to study drug (ferumoxytol or iron sucrose) and was based upon randomized treatment assignment. | Posted | Mean | Inter-Quartile Range | days | From Baseline (Day 1) up to Week 5 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferumoxytol | Participants received a total of 2 doses of IV ferumoxytol 510 mg (17 mL). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 g. | 17 | 406 | 95 | 406 | ||
| EG001 | Iron Sucrose | Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries. | 5 | 199 | 69 | 199 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (13.0) |
| ||
| Atrioventricular block second degree | Cardiac disorders | MedDRA (13.0) |
| ||
| Tachycardia | Cardiac disorders | MedDRA (13.0) |
| ||
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Asthenia | General disorders | MedDRA (13.0) |
| ||
| Pyrexia | General disorders | MedDRA (13.0) |
| ||
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA (13.0) |
| ||
| Anaphylactic reaction | Immune system disorders | MedDRA (13.0) |
| ||
| Bartholin's abscess | Infections and infestations | MedDRA (13.0) |
| ||
| Bronchopneumonia | Infections and infestations | MedDRA (13.0) |
| ||
| Rectal abscess | Infections and infestations | MedDRA (13.0) |
| ||
| Viraemia | Infections and infestations | MedDRA (13.0) |
| ||
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (13.0) |
| ||
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
| ||
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
| ||
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
| ||
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
| ||
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
| ||
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) |
| ||
| Dysuria | Renal and urinary disorders | MedDRA (13.0) |
| ||
| Uterine haemorrhage | Reproductive system and breast disorders | MedDRA (13.0) |
| ||
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (13.0) |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (13.0) |
| ||
| Hypertension | Vascular disorders | MedDRA (13.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Dry mouth | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Chest discomfort | General disorders | MedDRA (13.0) |
| ||
| Pyrexia | General disorders | MedDRA (13.0) |
| ||
| Chills | General disorders | MedDRA (13.0) |
| ||
| Urinary tract infection | Infections and infestations | MedDRA (13.0) |
| ||
| Cystitis | Infections and infestations | MedDRA (13.0) |
| ||
| Alanine aminotransferase increased | Investigations | MedDRA (13.0) |
| ||
| Aspartate aminotransferase increased | Investigations | MedDRA (13.0) |
| ||
| White blood cell count decreased | Investigations | MedDRA (13.0) |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
| ||
| Headache | Nervous system disorders | MedDRA (13.0) |
| ||
| Dizziness | Nervous system disorders | MedDRA (13.0) |
| ||
| Dysgeusia | Nervous system disorders | MedDRA (13.0) |
| ||
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (13.0) |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) |
| ||
| Hypertension | Vascular disorders | MedDRA (13.0) |
| ||
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.0) |
| ||
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) |
| ||
| Constipation | Gastrointestinal disorders | MedDRA (13.0) |
| ||
| Fatigue | General disorders | MedDRA (13.0) |
| ||
| Oedema peripheral | General disorders | MedDRA (13.0) |
| ||
| Feeling hot | General disorders | MedDRA (13.0) |
| ||
| Injection site pain | General disorders | MedDRA (13.0) |
| ||
| Hypersensitivity | Immune system disorders | MedDRA (13.0) |
| ||
| Drug hypersensitivity | Immune system disorders | MedDRA (13.0) |
| ||
| Influenza | Infections and infestations | MedDRA (13.0) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) |
| ||
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) |
| ||
| Lymphocyte count decreased | Investigations | MedDRA (13.0) |
| ||
| Gamma-glutamyltransferase increased | Investigations | MedDRA (13.0) |
| ||
| Blood urea decreased | Investigations | MedDRA (13.0) |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) |
| ||
| Somnolence | Nervous system disorders | MedDRA (13.0) |
| ||
| Hypotension | Vascular disorders | MedDRA (13.0) |
|
If there is no multi-site publication within 18 months after the Study has been completed or terminated at all Study sites, and all data have been received by Sponsor, the Site, and SMO shall have the right to publish its results from the Study for non-commercial purposes, if submitted to Sponsor for review 60 days prior to submission of publication. Publication must remove all confidential information and may be delayed by up to 180 days to allow Sponsor to protect its interests.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | AMAG Pharmaceuticals, Inc. | CTInterest@covispharma.com |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
| D008903 | Minerals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Up to Week 5 |
|
| Non-Inferiority |
The 95% confidence interval (CI) was calculated using the large sample assumption. The pre-defined non-inferiority margin for testing the difference between treatment groups was -15%. |
|
|
|
|
|
|
| Iron Sucrose |
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries. |
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