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Trial record 54 of 380 for:    FERRIC CATION

Evaluation of Efficacy and Safety of Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia and Impaired Renal Function (REPAIR-IDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00981045
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
Conditions Iron Deficiency Anemia
Impaired Renal Function
Interventions Drug: Ferric Carboxymaltose (FCM)
Drug: Iron Sucrose (Venofer)
Enrollment 2561
Recruitment Details 04-Sept-2009 through 15-Jun-2011; Hospitals and Medical Clinics
Pre-assignment Details 14 subjects randomized to FCM and 9 subjects randomized to Venofer were discontinued prior to dosing due to subject request or selection criteria/study compliance reasons.
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer)
Hide Arm/Group Description Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Period Title: Overall Study
Started 1290 1294
Completed 1276 1285
Not Completed 14 9
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer) Total
Hide Arm/Group Description Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg Total of all reporting groups
Overall Number of Baseline Participants 1276 1285 2561
Hide Baseline Analysis Population Description
14 subjects randomized to receive FCM and 9 subjects randomized to receive Venefor were randomized but discontinued prior to dosing due to subject request or selection criteria/study compliance reasons.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1276 participants 1285 participants 2561 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
468
  36.7%
500
  38.9%
968
  37.8%
>=65 years
808
  63.3%
785
  61.1%
1593
  62.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1276 participants 1285 participants 2561 participants
67.5  (13.00) 67.2  (13.00) 67.3  (12.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1276 participants 1285 participants 2561 participants
Female
810
  63.5%
818
  63.7%
1628
  63.6%
Male
466
  36.5%
467
  36.3%
933
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1276 participants 1285 participants 2561 participants
1276 1285 2561
1.Primary Outcome
Title Mean Change From Baseline to the Highest Observed Hemoglobin Any Time From Baseline to End of Study.
Hide Description [Not Specified]
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer)
Hide Arm/Group Description:
Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Overall Number of Participants Analyzed 1249 1244
Mean (Standard Deviation)
Unit of Measure: g/dL
1.13  (1.044) 0.92  (0.917)
2.Primary Outcome
Title Proportion of Subjects Experiencing at Least One Event in the Primary Composite Safety Endpoint in the Randomized Population.
Hide Description The primary composite safety endpoint was defined as death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization or medical intervention, arrhythmias, protocol-defined hypersensitive events, and protocol-defined hyposensitive events.
Time Frame Day 120
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer)
Hide Arm/Group Description:
Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
Overall Number of Participants Analyzed 1276 1285
Measure Type: Number
Unit of Measure: participants
175 156
Time Frame September 4, 2009 through June 15, 2011
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer)
Hide Arm/Group Description Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
All-Cause Mortality
Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer)
Affected / at Risk (%) Affected / at Risk (%)
Total   202/1276 (15.83%)   197/1285 (15.33%) 
Blood and lymphatic system disorders     
Anemia  14/1276 (1.10%)  4/1285 (0.31%) 
Coagulopathy  0/1276 (0.00%)  1/1285 (0.08%) 
Normochromic normocytic anemia  0/1276 (0.00%)  1/1285 (0.08%) 
Pancytopenia  0/1276 (0.00%)  1/1285 (0.08%) 
Cardiac disorders     
Acute myocardial infarction  6/1276 (0.47%)  11/1285 (0.86%) 
Angina pectoris  6/1276 (0.47%)  3/1285 (0.23%) 
Angina unstable  6/1276 (0.47%)  3/1285 (0.23%) 
Aortic valve stenosis  1/1276 (0.08%)  0/1285 (0.00%) 
Arrhythmia  2/1276 (0.16%)  1/1285 (0.08%) 
Arteriospasm coronary  0/1276 (0.00%)  1/1285 (0.08%) 
Atrial fibrillation  6/1276 (0.47%)  2/1285 (0.16%) 
Atrial flutter  1/1276 (0.08%)  1/1285 (0.08%) 
Atrioventricular block second degree  0/1276 (0.00%)  1/1285 (0.08%) 
Bifascicular block  1/1276 (0.08%)  0/1285 (0.00%) 
Bradycardia  3/1276 (0.24%)  4/1285 (0.31%) 
Cardiac arrest  0/1276 (0.00%)  4/1285 (0.31%) 
Cardiac failure  1/1276 (0.08%)  0/1285 (0.00%) 
Cardiac failure acute  1/1276 (0.08%)  0/1285 (0.00%) 
Cardiac failure chronic  0/1276 (0.00%)  1/1285 (0.08%) 
Cardiac failure congestive  30/1276 (2.35%)  29/1285 (2.26%) 
Cardio-respiratory arrest  2/1276 (0.16%)  3/1285 (0.23%) 
Cardiogenic shock  0/1276 (0.00%)  1/1285 (0.08%) 
Coronary artery disease  5/1276 (0.39%)  3/1285 (0.23%) 
Ischemic cardiomyopathy  1/1276 (0.08%)  0/1285 (0.00%) 
Myocardial infarction  3/1276 (0.24%)  5/1285 (0.39%) 
Myocardial ischemia  1/1276 (0.08%)  0/1285 (0.00%) 
Nodal arrhythmia  1/1276 (0.08%)  0/1285 (0.00%) 
Palpitations  2/1276 (0.16%)  0/1285 (0.00%) 
Pericarditis  1/1276 (0.08%)  0/1285 (0.00%) 
Right ventricular failure  1/1276 (0.08%)  1/1285 (0.08%) 
Sick sinus syndrome  2/1276 (0.16%)  0/1285 (0.00%) 
Sinus bradycardia  2/1276 (0.16%)  0/1285 (0.00%) 
Superventricular tachycardia  1/1276 (0.08%)  1/1285 (0.08%) 
Ventricular tachycardia  1/1276 (0.08%)  1/1285 (0.08%) 
Ear and labyrinth disorders     
Vertigo  1/1276 (0.08%)  2/1285 (0.16%) 
Eye disorders     
Retinal vein occlusion  0/1276 (0.00%)  1/1285 (0.08%) 
Gastrointestinal disorders     
Abdominal pain  1/1276 (0.08%)  1/1285 (0.08%) 
Colitis  1/1276 (0.08%)  1/1285 (0.08%) 
Constipation  1/1276 (0.08%)  0/1285 (0.00%) 
Crohn's disease  1/1276 (0.08%)  0/1285 (0.00%) 
Diarrhea  0/1276 (0.00%)  2/1285 (0.16%) 
Duodenal ulcer hemorrhage  0/1276 (0.00%)  1/1285 (0.08%) 
Enterocolitis  1/1276 (0.08%)  0/1285 (0.00%) 
Fecaloma  1/1276 (0.08%)  0/1285 (0.00%) 
Gastric ulcer  0/1276 (0.00%)  1/1285 (0.08%) 
Gastritis  1/1276 (0.08%)  0/1285 (0.00%) 
Gastritis hemorrhagic  1/1276 (0.08%)  0/1285 (0.00%) 
Gastrointestinal hemorrhage  9/1276 (0.71%)  9/1285 (0.70%) 
Gastroesophageal reflux disease  2/1276 (0.16%)  0/1285 (0.00%) 
Hematemesis  0/1276 (0.00%)  1/1285 (0.08%) 
Hemorrhoids  0/1276 (0.00%)  1/1285 (0.08%) 
Inguinal hernia, obstructive  1/1276 (0.08%)  0/1285 (0.00%) 
Intestinal ischemia  1/1276 (0.08%)  0/1285 (0.00%) 
Intestinal mass  0/1276 (0.00%)  1/1285 (0.08%) 
Intra-abdominal hematoma  0/1276 (0.00%)  1/1285 (0.08%) 
Pancreatic mass  0/1276 (0.00%)  2/1285 (0.16%) 
Pancreatitis  0/1276 (0.00%)  3/1285 (0.23%) 
Pancreatitis relapsing  0/1276 (0.00%)  1/1285 (0.08%) 
Peritonitis  1/1276 (0.08%)  0/1285 (0.00%) 
Small intestinal obstruction  2/1276 (0.16%)  2/1285 (0.16%) 
Upper gastrointestinal hemorrhage  0/1276 (0.00%)  2/1285 (0.16%) 
General disorders     
Asthenia  0/1276 (0.00%)  2/1285 (0.16%) 
Chest pain  1/1276 (0.08%)  4/1285 (0.31%) 
Fatigue  2/1276 (0.16%)  0/1285 (0.00%) 
Gait disturbance  1/1276 (0.08%)  1/1285 (0.08%) 
Generalized edema  1/1276 (0.08%)  2/1285 (0.16%) 
Hernia obstructive  0/1276 (0.00%)  1/1285 (0.08%) 
Non-cardiac chest pain  3/1276 (0.24%)  3/1285 (0.23%) 
Edema peripheral  1/1276 (0.08%)  0/1285 (0.00%) 
Sudden cardiac death  0/1276 (0.00%)  1/1285 (0.08%) 
Ulcer hemorrhage  1/1276 (0.08%)  0/1285 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1/1276 (0.08%)  1/1285 (0.08%) 
Cholelithiasis  0/1276 (0.00%)  1/1285 (0.08%) 
Hepatotoxicity  0/1276 (0.00%)  1/1285 (0.08%) 
Jaundice cholestatic  0/1276 (0.00%)  1/1285 (0.08%) 
Immune system disorders     
Anaphylactic reaction  1/1276 (0.08%)  0/1285 (0.00%) 
Anaphylactoid reaction  1/1276 (0.08%)  0/1285 (0.00%) 
Hypersensitivity  1/1276 (0.08%)  0/1285 (0.00%) 
Pancreas transplant rejection  0/1276 (0.00%)  1/1285 (0.08%) 
Infections and infestations     
Appendicitis  1/1276 (0.08%)  1/1285 (0.08%) 
Bacteremia  0/1276 (0.00%)  1/1285 (0.08%) 
Bacterial pyelonephritis  1/1276 (0.08%)  0/1285 (0.00%) 
Bronchitis  2/1276 (0.16%)  1/1285 (0.08%) 
Bronchopneumonia  1/1276 (0.08%)  0/1285 (0.00%) 
Cellulitis  10/1276 (0.78%)  6/1285 (0.47%) 
Cellulitis of male external genital organ  1/1276 (0.08%)  0/1285 (0.00%) 
Cystitis  1/1276 (0.08%)  1/1285 (0.08%) 
Diverticulitis  0/1276 (0.00%)  1/1285 (0.08%) 
Empyema  1/1276 (0.08%)  1/1285 (0.08%) 
Endocarditis  0/1276 (0.00%)  1/1285 (0.08%) 
Enterocolitis bacterial  0/1276 (0.00%)  1/1285 (0.08%) 
Gangrene  0/1276 (0.00%)  1/1285 (0.08%) 
Gastroenteritis  5/1276 (0.39%)  1/1285 (0.08%) 
Herpes zoster  0/1276 (0.00%)  1/1285 (0.08%) 
Herpes zoster ophthalmic  0/1276 (0.00%)  1/1285 (0.08%) 
Influenza  0/1276 (0.00%)  1/1285 (0.08%) 
Lobar pneumonia  2/1276 (0.16%)  1/1285 (0.08%) 
Osteomyelitis  2/1276 (0.16%)  3/1285 (0.23%) 
Pneumonia  15/1276 (1.18%)  16/1285 (1.25%) 
Pneumonia streptococcal  0/1276 (0.00%)  1/1285 (0.08%) 
Postoperative wound infection  0/1276 (0.00%)  1/1285 (0.08%) 
Pyelonephritis  0/1276 (0.00%)  1/1285 (0.08%) 
Pyelonephritis acute  1/1276 (0.08%)  1/1285 (0.08%) 
Renal cyst infection  0/1276 (0.00%)  1/1285 (0.08%) 
Sepsis  2/1276 (0.16%)  4/1285 (0.31%) 
Septic shock  0/1276 (0.00%)  2/1285 (0.16%) 
Sinusitis  0/1276 (0.00%)  1/1285 (0.08%) 
Staphylococcal bacteremia  0/1276 (0.00%)  1/1285 (0.08%) 
Staphy;ococcal infection  0/1276 (0.00%)  1/1285 (0.08%) 
Tracheobronchitis  1/1276 (0.08%)  0/1285 (0.00%) 
Urinary tract infection  10/1276 (0.78%)  2/1285 (0.16%) 
Urosepsis  0/1276 (0.00%)  3/1285 (0.23%) 
Wound infection  1/1276 (0.08%)  0/1285 (0.00%) 
Injury, poisoning and procedural complications     
Device lead damage  1/1276 (0.08%)  0/1285 (0.00%) 
Drug toxicity  1/1276 (0.08%)  0/1285 (0.00%) 
Face injury  1/1276 (0.08%)  0/1285 (0.00%) 
Femoral neck fracture  0/1276 (0.00%)  1/1285 (0.08%) 
Femur fracture  1/1276 (0.08%)  1/1285 (0.08%) 
Fractured sacrum  1/1276 (0.08%)  0/1285 (0.00%) 
Gastrointestinal stoma complication  0/1276 (0.00%)  1/1285 (0.08%) 
Head injury  0/1276 (0.00%)  1/1285 (0.08%) 
Hip fracture  3/1276 (0.24%)  0/1285 (0.00%) 
Spinal compression fracture  1/1276 (0.08%)  0/1285 (0.00%) 
Urostomy complication  0/1276 (0.00%)  1/1285 (0.08%) 
Investigations     
Blood glucose decreased  0/1276 (0.00%)  1/1285 (0.08%) 
International normalized ratio increased  0/1276 (0.00%)  1/1285 (0.08%) 
Liver function abnormal  1/1276 (0.08%)  0/1285 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1/1276 (0.08%)  0/1285 (0.00%) 
Dehydration  3/1276 (0.24%)  5/1285 (0.39%) 
Diabetes mellitus  0/1276 (0.00%)  1/1285 (0.08%) 
Diabetes mellitus inadequate control  1/1276 (0.08%)  0/1285 (0.00%) 
Diabetic ketoacidosis  2/1276 (0.16%)  0/1285 (0.00%) 
Electrolyte imbalance  1/1276 (0.08%)  0/1285 (0.00%) 
Failure to thrive  2/1276 (0.16%)  0/1285 (0.00%) 
Fluid overload  1/1276 (0.08%)  1/1285 (0.08%) 
Gout  1/1276 (0.08%)  0/1285 (0.00%) 
Hypercalcemia  1/1276 (0.08%)  0/1285 (0.00%) 
Hyperkalemia  6/1276 (0.47%)  1/1285 (0.08%) 
Hypoglycemia  7/1276 (0.55%)  6/1285 (0.47%) 
Hypokalemia  0/1276 (0.00%)  1/1285 (0.08%) 
Hyponatremia  3/1276 (0.24%)  1/1285 (0.08%) 
Hypovolemia  1/1276 (0.08%)  0/1285 (0.00%) 
Metabolic acidosis  1/1276 (0.08%)  0/1285 (0.00%) 
Type 2 diabetes mellitus  0/1276 (0.00%)  1/1285 (0.08%) 
Musculoskeletal and connective tissue disorders     
Costochondritis  1/1276 (0.08%)  0/1285 (0.00%) 
Intervertebral disc degeneration  0/1276 (0.00%)  1/1285 (0.08%) 
Musculoskeletal chest pain  1/1276 (0.08%)  2/1285 (0.16%) 
Osteoarthritis  1/1276 (0.08%)  0/1285 (0.00%) 
Rhabdomyolysis  0/1276 (0.00%)  1/1285 (0.08%) 
Scleroderma  1/1276 (0.08%)  0/1285 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Angiomyolipoma  0/1276 (0.00%)  1/1285 (0.08%) 
Bladder cancer  0/1276 (0.00%)  2/1285 (0.16%) 
Colon cancer  0/1276 (0.00%)  1/1285 (0.08%) 
Meningioma  1/1276 (0.08%)  0/1285 (0.00%) 
Metastatic renal cell carcinoma  1/1276 (0.08%)  0/1285 (0.00%) 
Non-small cell lung cancer  0/1276 (0.00%)  1/1285 (0.08%) 
Ovarian cancer  0/1276 (0.00%)  1/1285 (0.08%) 
Prostate cancer  0/1276 (0.00%)  1/1285 (0.08%) 
Rectal cancer  1/1276 (0.08%)  0/1285 (0.00%) 
Renal cancer metastatic  1/1276 (0.08%)  0/1285 (0.00%) 
Renal cell carcinoma recurrent  0/1276 (0.00%)  1/1285 (0.08%) 
Thyroid cancer  1/1276 (0.08%)  0/1285 (0.00%) 
Uterine leiomyoma  0/1276 (0.00%)  1/1285 (0.08%) 
Nervous system disorders     
Cerebrovascular accident  4/1276 (0.31%)  1/1285 (0.08%) 
Convulsion  0/1276 (0.00%)  1/1285 (0.08%) 
Dizziness  0/1276 (0.00%)  3/1285 (0.23%) 
Embolic stroke  0/1276 (0.00%)  1/1285 (0.08%) 
Encephalopathy  1/1276 (0.08%)  0/1285 (0.00%) 
Hypoglycemic coma  1/1276 (0.08%)  0/1285 (0.00%) 
Normal pressure hydrocephalus  0/1276 (0.00%)  1/1285 (0.08%) 
Sedation  0/1276 (0.00%)  1/1285 (0.08%) 
Subarachnoid hemorrhage  1/1276 (0.08%)  0/1285 (0.00%) 
Syncope  1/1276 (0.08%)  5/1285 (0.39%) 
Syncope vasovagal  0/1276 (0.00%)  1/1285 (0.08%) 
Transient ischemic attack  0/1276 (0.00%)  4/1285 (0.31%) 
Psychiatric disorders     
Delirium  1/1276 (0.08%)  0/1285 (0.00%) 
Mental disorder  1/1276 (0.08%)  0/1285 (0.00%) 
Mental status change  2/1276 (0.16%)  1/1285 (0.08%) 
Renal and urinary disorders     
Azotemia  2/1276 (0.16%)  1/1285 (0.08%) 
Hematuria  1/1276 (0.08%)  0/1285 (0.00%) 
Nephritis  0/1276 (0.00%)  1/1285 (0.08%) 
Nephrotic syndrome  1/1276 (0.08%)  0/1285 (0.00%) 
Obstructive uropathy  2/1276 (0.16%)  0/1285 (0.00%) 
Renal artery occlusion  1/1276 (0.08%)  0/1285 (0.00%) 
Renal failure  4/1276 (0.31%)  8/1285 (0.62%) 
Renal failure acute  13/1276 (1.02%)  11/1285 (0.86%) 
Renal failure chronic  10/1276 (0.78%)  10/1285 (0.78%) 
Renal impairment  0/1276 (0.00%)  2/1285 (0.16%) 
Urinary retention  0/1276 (0.00%)  1/1285 (0.08%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1/1276 (0.08%)  0/1285 (0.00%) 
Epididymitis  1/1276 (0.08%)  0/1285 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  0/1276 (0.00%)  3/1285 (0.23%) 
Asthma  2/1276 (0.16%)  0/1285 (0.00%) 
Chronic obstructive pulmonary disease  9/1276 (0.71%)  7/1285 (0.54%) 
Dyspnea  2/1276 (0.16%)  1/1285 (0.08%) 
Dyspnea paroxysmal nocturnal  0/1276 (0.00%)  1/1285 (0.08%) 
Epistaxis  0/1276 (0.00%)  1/1285 (0.08%) 
Obstructive airways disorder  0/1276 (0.00%)  1/1285 (0.08%) 
Pleural effusion  1/1276 (0.08%)  1/1285 (0.08%) 
Pulmonary fibrosis  0/1276 (0.00%)  1/1285 (0.08%) 
Pulmonary edema  0/1276 (0.00%)  2/1285 (0.16%) 
Respiratory failure  1/1276 (0.08%)  2/1285 (0.16%) 
Skin and subcutaneous tissue disorders     
Angiedema  0/1276 (0.00%)  1/1285 (0.08%) 
Dermatitis allergic  1/1276 (0.08%)  0/1285 (0.00%) 
Drug eruption  0/1276 (0.00%)  1/1285 (0.08%) 
Rash  0/1276 (0.00%)  1/1285 (0.08%) 
Skin ulcer  1/1276 (0.08%)  1/1285 (0.08%) 
Vascular disorders     
Aortic dissection  1/1276 (0.08%)  0/1285 (0.00%) 
Aortic stenosis  0/1276 (0.00%)  1/1285 (0.08%) 
Arterial stenosis  0/1276 (0.00%)  1/1285 (0.08%) 
Arterial thrombosis  0/1276 (0.00%)  1/1285 (0.08%) 
Deep vein thrombosis  2/1276 (0.16%)  0/1285 (0.00%) 
Hypertension  3/1276 (0.24%)  2/1285 (0.16%) 
Hypertensive crisis  0/1276 (0.00%)  2/1285 (0.16%) 
Hypertensive emergency  0/1276 (0.00%)  1/1285 (0.08%) 
Hypotension  3/1276 (0.24%)  2/1285 (0.16%) 
Malignant hypertension  1/1276 (0.08%)  0/1285 (0.00%) 
Peripheral ischemia  1/1276 (0.08%)  0/1285 (0.00%) 
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%
Ferric Carboxymaltose (FCM) Iron Sucrose (Venofer)
Affected / at Risk (%) Affected / at Risk (%)
Total   305/1276 (23.90%)   151/1285 (11.75%) 
Gastrointestinal disorders     
Nausea  172/1276 (13.48%)  56/1285 (4.36%) 
Vascular disorders     
Hypertension  133/1276 (10.42%)  95/1285 (7.39%) 
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
Layout table for Results Point of Contact information
Name/Title: Mark A. Falone, MD
Organization: Luitpold Pharmaceuticals, Inc.
Phone: 610-650-4200
EMail: mfalone@luitpold.com
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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00981045     History of Changes
Other Study ID Numbers: 1VIT09030
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