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Trial record 19 of 46 for:    FERRIC SULFATE

Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

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ClinicalTrials.gov Identifier: NCT00982007
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : October 18, 2013
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Iron Deficiency Anemia
Interventions Drug: Ferric Carboxymaltose (FCM)
Drug: Ferrous Sulfate Tablets
Drug: IV Iron (standard of care)
Enrollment 997
Recruitment Details Hospitals and Medical Clinics
Pre-assignment Details  
Arm/Group Title Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Cohort 1 (Group B) - Ferrous Sulfate Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Cohort 2 (Group D) - IV Iron (Standard of Care)
Hide Arm/Group Description

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Oral iron

Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Other IV iron

IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion

Period Title: Overall Study
Started 250 257 253 251
Completed 246 253 253 245
Not Completed 4 4 0 6
Arm/Group Title Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Cohort 1 (Group B) - Ferrous Sulfate Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Cohort 2 (Group D) - IV Iron (Standard of Care) Total
Hide Arm/Group Description

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Oral iron

Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion Total of all reporting groups
Overall Number of Baseline Participants 246 253 253 245 997
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 253 participants 253 participants 245 participants 997 participants
<=18 years
2
   0.8%
7
   2.8%
2
   0.8%
3
   1.2%
14
   1.4%
Between 18 and 65 years
209
  85.0%
208
  82.2%
216
  85.4%
218
  89.0%
851
  85.4%
>=65 years
35
  14.2%
38
  15.0%
35
  13.8%
24
   9.8%
132
  13.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants 253 participants 253 participants 245 participants 997 participants
43.1  (17.18) 43.5  (17.71) 43.6  (16.88) 42.6  (15.51) 43.2  (16.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants 253 participants 253 participants 245 participants 997 participants
Female
233
  94.7%
238
  94.1%
239
  94.5%
231
  94.3%
941
  94.4%
Male
13
   5.3%
15
   5.9%
14
   5.5%
14
   5.7%
56
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 246 participants 253 participants 253 participants 245 participants 997 participants
246 253 253 245 997
1.Primary Outcome
Title Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
Hide Description [Not Specified]
Time Frame Day 35
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population: Subjects who have received at least 1 dose of randomized study medication and had at least 1 post-baseline hemoglobin assessment
Arm/Group Title Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Cohort 1 (Group B) - Ferrous Sulfate Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Cohort 2 (Group D) - IV Iron (Standard of Care)
Hide Arm/Group Description:

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Oral iron

Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Other IV iron

IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion

Overall Number of Participants Analyzed 244 251 245 237
Mean (Standard Deviation)
Unit of Measure: g/dL
1.57  (1.194) 0.80  (0.799) 2.90  (1.640) 2.16  (1.252)
Time Frame 1 year and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Cohort 1 (Group B) - Ferrous Sulfate Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Cohort 2 (Group D) - IV Iron (Standard of Care)
Hide Arm/Group Description

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Oral iron

Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day

Intravenous (IV) iron

Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.

Other IV iron

IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion

All-Cause Mortality
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Cohort 1 (Group B) - Ferrous Sulfate Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Cohort 2 (Group D) - IV Iron (Standard of Care)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Cohort 1 (Group B) - Ferrous Sulfate Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Cohort 2 (Group D) - IV Iron (Standard of Care)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/246 (3.25%)   10/253 (3.95%)   17/253 (6.72%)   16/245 (6.53%) 
Blood and lymphatic system disorders         
Anemia  1  1/246 (0.41%)  0/253 (0.00%)  2/253 (0.79%)  1/245 (0.41%) 
Cardiac disorders         
Acute myocardial infarction  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Angina pectoris  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Atrial fibrillation  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Congenital, familial and genetic disorders         
Cystic fibrosis  1  1/246 (0.41%)  0/253 (0.00%)  0/253 (0.00%)  0/245 (0.00%) 
Gastrointestinal disorders         
Colitis  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Gastrointestinal hemorrhage  1  1/246 (0.41%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Small intestinal obstruction  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Volvulus  1  1/246 (0.41%)  0/253 (0.00%)  0/253 (0.00%)  0/245 (0.00%) 
General disorders         
Chest pain  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Death  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Fatigue  1  1/246 (0.41%)  0/253 (0.00%)  0/253 (0.00%)  0/245 (0.00%) 
Hepatobiliary disorders         
Bile duct stone  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Cholecystitis  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Cholelithiasis  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Immune system disorders         
Hypersensitivity  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  3/245 (1.22%) 
Infections and infestations         
Bacteremia  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Herpes zoster  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Mastitis  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Pneumonia  1  1/246 (0.41%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Septic shock  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Drug toxicity  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Metabolism and nutrition disorders         
Hyperkalemia  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Lung neoplasm malignant  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Uterine cancer  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Uterine leiomyoma  1  1/246 (0.41%)  0/253 (0.00%)  0/253 (0.00%)  0/245 (0.00%) 
Nervous system disorders         
Carpal tunnel syndrome  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Cerebrovascular accident  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Paresthesia  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Transient ischemic attack  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Pregnancy, puerperium and perinatal conditions         
Abortion spontaneous  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Psychiatric disorders         
Depression  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Suicidal ideation  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  0/245 (0.00%) 
Suicide attempt  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  1/245 (0.41%) 
Reproductive system and breast disorders         
Menorrhagia  1  1/246 (0.41%)  0/253 (0.00%)  2/253 (0.79%)  2/245 (0.82%) 
Pelvic pain  1  1/246 (0.41%)  0/253 (0.00%)  0/253 (0.00%)  0/245 (0.00%) 
Uterine disorder  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Uterine hemorrhage  1  0/246 (0.00%)  1/253 (0.40%)  0/253 (0.00%)  1/245 (0.41%) 
Vaginal hemorrhage  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Respiratory, thoracic and mediastinal disorders         
Acute respiratory failure  1  0/246 (0.00%)  0/253 (0.00%)  0/253 (0.00%)  1/245 (0.41%) 
Pulmonary hypertension  1  0/246 (0.00%)  0/253 (0.00%)  1/253 (0.40%)  0/245 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM) Cohort 1 (Group B) - Ferrous Sulfate Cohort 2 (Group C) - Ferric Carboxymaltose (FCM) Cohort 2 (Group D) - IV Iron (Standard of Care)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   31/246 (12.60%)   5/253 (1.98%)   26/253 (10.28%)   10/245 (4.08%) 
Gastrointestinal disorders         
Nausea  1  20/246 (8.13%)  5/253 (1.98%)  10/253 (3.95%)  10/245 (4.08%) 
Metabolism and nutrition disorders         
Hypophosphatemia  1  11/246 (4.47%)  0/253 (0.00%)  16/253 (6.32%)  0/245 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Mark A. Falone
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00982007     History of Changes
Other Study ID Numbers: 1VIT09031
First Submitted: September 21, 2009
First Posted: September 22, 2009
Results First Submitted: August 14, 2013
Results First Posted: October 18, 2013
Last Update Posted: February 20, 2018