Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ferric Carboxymaltose (FCM) Assessment in Subjects With Iron Deficiency Anaemia and Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (FIND-CKD)

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: NCT00994318
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : May 7, 2014
Last Update Posted : May 20, 2014
Sponsor:
Collaborators:
American Regent, Inc.
ICON Clinical Research
Information provided by (Responsible Party):
Vifor Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Iron Deficiency Anaemia
Chronic Kidney Disease
Interventions Drug: FCM (Ferric carboxymaltose) high ferritin target
Drug: FCM (Ferric carboxymaltose) low ferritin target
Drug: Oral Iron (Ferrous sulphate)
Enrollment 626
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FCM (High Ferritin Target) FCM (Low Ferritin Target) Oral Iron
Hide Arm/Group Description Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L Ferrous sulphate 100 mg iron twice daily, continuous
Period Title: Overall Study
Started 155 154 317
Completed 133 136 250
Not Completed 22 18 67
Arm/Group Title FCM (High Ferritin Target FCM (Low Ferritin Target) Oral Iron Total
Hide Arm/Group Description Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L Ferrous sulphate 100 mg iron twice daily, continuous Total of all reporting groups
Overall Number of Baseline Participants 153 152 308 613
Hide Baseline Analysis Population Description
Baseline analysis population is the Full Analysis Set (FAS); all subjects randomised to treatment, received at least 1 dose study drug or, per protocol, not treated due to ferritin <100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment. Overall 626 subjects were randomised, the FAS consists of 613 subjects.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 308 participants 613 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
  26.8%
49
  32.2%
92
  29.9%
182
  29.7%
>=65 years
112
  73.2%
103
  67.8%
216
  70.1%
431
  70.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 152 participants 308 participants 613 participants
69.46  (12.643) 68.19  (13.264) 69.31  (13.404) 69.07  (13.172)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 308 participants 613 participants
Female
91
  59.5%
98
  64.5%
192
  62.3%
381
  62.2%
Male
62
  40.5%
54
  35.5%
116
  37.7%
232
  37.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 308 participants 613 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   1.3%
3
   2.0%
9
   2.9%
14
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   0.3%
1
   0.2%
Black or African American
2
   1.3%
5
   3.3%
7
   2.3%
14
   2.3%
White
149
  97.4%
144
  94.7%
291
  94.5%
584
  95.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 153 participants 152 participants 308 participants 613 participants
United States 4 3 7 14
Portugal 2 2 5 9
Greece 28 28 55 111
Turkey 7 7 15 29
Austria 2 2 4 8
United Kingdom 17 18 36 71
Italy 10 10 19 39
France 1 0 3 4
Czech Republic 16 15 31 62
Belgium 3 3 4 10
Poland 11 11 20 42
Romania 2 2 4 8
Australia 15 16 31 62
Denmark 1 1 2 4
Germany 26 25 49 100
Netherlands 4 4 8 16
Norway 0 1 4 5
Sweden 0 0 1 1
Spain 4 4 10 18
1.Primary Outcome
Title Kaplan-Meier Survival Analysis for Time to Other Anemia Therapy or Hb Trigger
Hide Description

Endpoint reported number of participants with/without events and was reached:

  • First time of initiation of additional or alternative anaemia management,
  • First time the subject reached the Hb trigger.

    3 primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve an alpha level of 0.05, performed in the following order:

    1. FCM (high ferritin target) compared with oral iron.
    2. FCM (high ferritin target) compared with FCM (low ferritin target).
    3. FCM (low ferritin target) compared with oral iron.

Sensitivity analyses of the primary endpoint were performed using the following alternative definitions of time to initiation of additional or alternative anaemia management:

  1. Without taking into account the Hb trigger.
  2. Taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.
  3. Taking into account the Hb trigger based on subjects with a complete set of Hb values from the central laboratory.
Time Frame Up to 1 year after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) was used for the primary endpoint analysis, which consisted of all subjects randomised to treatment, received at least 1 dose of study treatment or, according to the protocol, were not treated due to ferritin value <100 mcg/L, and attended at least 1 post-baseline visit with at least 1 non-missing assessment available.
Arm/Group Title FCM (High Ferritin Target) FCM (Low Ferritin Level) Oral Iron
Hide Arm/Group Description:
Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 400-600 mcg/L
Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 100-200 mcg/L
Ferrous sulphate 100 mg iron twice daily, continuous
Overall Number of Participants Analyzed 153 152 308
Measure Type: Number
Unit of Measure: participants
Number of patients with events 36 49 98
Number of patients without events 117 103 210
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FCM (High Ferritin Target), Oral Iron
Comments

FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).

Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:

  1. FCM (high ferritin target) compared with oral iron.
  2. FCM (high ferritin target) compared with FCM (low ferritin target).
  3. FCM (low ferritin target) compared with oral iron.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.44 to 0.95
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection FCM (High Ferritin Target), FCM (Low Ferritin Level)
Comments

FCM (Ferinject / Injectafer) targeting high ferritin level (400-600mcg/L) compared with FCM targeting low ferritin level (100 - 200 mcg/L).

Three primary comparisons using a hierarchical step-down procedure on the log-rank test to preserve the overall alpha level of 0.05, performed in the following order:

  1. FCM (high ferritin target) compared with oral iron.
  2. FCM (high ferritin target) compared with FCM (low ferritin target).
  3. FCM (low ferritin target) compared with oral iron.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.082
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.45 to 1.05
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection FCM (High Ferritin Target), Oral Iron
Comments

Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management without taking into account the Hb trigger.

FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.39 to 0.93
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection FCM (High Ferritin Target), FCM (Low Ferritin Level)
Comments

Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on local laboratory data, instead of central laboratory data.

FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily).

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.43 to 0.88
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection FCM (High Ferritin Target), Oral Iron
Comments

Sensitivity analysis of the primary endpoint. Time to initiation of additional or alternative anaemia management taking into account the Hb trigger based on subjects with a complete set of Hb values from central laboratory.

FCM (Ferinject / Injectafer) targeting high ferritin level (400 - 600 mcg/L) compared with Oral Iron (Ferrous sulphate 100 mg iron twice daily)

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.70
Confidence Interval (2-Sided) 95%
0.45 to 1.10
Estimation Comments [Not Specified]
Time Frame Adverse Event data was collected for 56 weeks after baseline.
Adverse Event Reporting Description The Number of Patients at Risk is the Safety Set which consists of all randomised subjects who received at least 1 dose of study drug.
 
Arm/Group Title FCM (High Ferritin Target) FCM (Low Ferritin Target) Oral Iron
Hide Arm/Group Description Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L Ferrous sulphate 100 mg iron twice daily, continuous
All-Cause Mortality
FCM (High Ferritin Target) FCM (Low Ferritin Target) Oral Iron
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FCM (High Ferritin Target) FCM (Low Ferritin Target) Oral Iron
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   39/154 (25.32%)   36/150 (24.00%)   59/312 (18.91%) 
Blood and lymphatic system disorders       
Anaemia  1  1/154 (0.65%)  2/150 (1.33%)  1/312 (0.32%) 
Nephrogenic Anaemia  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Pancytopenia  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Cardiac disorders       
Acute Myocardial Infarction  1  2/154 (1.30%)  0/150 (0.00%)  4/312 (1.28%) 
Cardiac Failure  1  1/154 (0.65%)  0/150 (0.00%)  3/312 (0.96%) 
Cardiac Failure Congestive  1  2/154 (1.30%)  1/150 (0.67%)  1/312 (0.32%) 
Acute Coronary Syndrome  1  2/154 (1.30%)  0/150 (0.00%)  1/312 (0.32%) 
Myocardial Infarction  1  1/154 (0.65%)  1/150 (0.67%)  1/312 (0.32%) 
Cardiac Arrest  1  1/154 (0.65%)  0/150 (0.00%)  1/312 (0.32%) 
Coronary Artery Disease  1  0/154 (0.00%)  1/150 (0.67%)  1/312 (0.32%) 
Angina Unstable  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Arrhythmia  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Atrial Fibrillation  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Atrioventricular Block Complete  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Cardiac Failure Acute  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Extrasystoles  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Hypertensive Heart Disease  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Left Ventricular Dysfunction  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Myocardial Ischaemia  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Sinus Arrhythmia  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Gastrointestinal disorders       
Diarrhoea  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Duodenal Ulcer  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Duodenal Ulcer Haemorrhage  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Duodenitis  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Dyspepsia  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Entercolitis  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Gastric Ulcer  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Gastrointestinal Haemorrhage  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Haematemesis  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Pancreatic Disorder  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Pancreatitis  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Umbilical Hernia, Obstructive  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
General disorders       
Chest Pain  1  1/154 (0.65%)  1/150 (0.67%)  0/312 (0.00%) 
Device Failure  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Fatigue  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Hernia Obstructive  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Non-Cardiac Chest Pain  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Immune system disorders       
Drug Hypersensitivity  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Infections and infestations       
Pneumonia  1  0/154 (0.00%)  1/150 (0.67%)  4/312 (1.28%) 
Urinary Tract Infection  1  1/154 (0.65%)  0/150 (0.00%)  2/312 (0.64%) 
Infective Exacerbation of Chronic Obstructive Airways Disease  1  1/154 (0.65%)  0/150 (0.00%)  1/312 (0.32%) 
Pyelonephritis  1  1/154 (0.65%)  1/150 (0.67%)  0/312 (0.00%) 
Sepsis  1  0/154 (0.00%)  1/150 (0.67%)  1/312 (0.32%) 
Abscess  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Bacteraemia  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Bronchopneumonia  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Cellulitis  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Cystitis  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Endophthalmitis  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Infected Skin Ulcer  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Infection  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Respiratory Tract Infection  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Staphylococcal Sepsis  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Upper Respiratory Tract Infection  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Urosepsis  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Viral Upper Respiratory Tract Infection  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Wound Abscess  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Wound Infection Staphlyococcal  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Injury, poisoning and procedural complications       
Tibia Fracture  1  1/154 (0.65%)  0/150 (0.00%)  1/312 (0.32%) 
Cervical Vertebral Fracture  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Concussion  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Femur Fracture  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Humerus Fracture  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Laceration  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Ligament Rupture  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Multiple Injuries  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Overdose  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Pelvic Fracture  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Perirenal Haematoma  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Renal Haematoma  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Rib Fracture  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Spinal Fracture  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Upper Limb Fracture  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Investigations       
Haemoglobin Decreased  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
International Normalised Ratio Increased  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Metabolism and nutrition disorders       
Hypoglycaemia  1  1/154 (0.65%)  1/150 (0.67%)  5/312 (1.60%) 
Diabetes Mellitus  1  0/154 (0.00%)  3/150 (2.00%)  1/312 (0.32%) 
Diabetic foot  1  1/154 (0.65%)  1/150 (0.67%)  0/312 (0.00%) 
Dehydration  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Diabetic Ketoacidosis  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Fluid overload  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Fluid Retention  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Hyperkalaemia  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  2/154 (1.30%)  1/150 (0.67%)  0/312 (0.00%) 
Lumbar Spinal Stenosis  1  0/154 (0.00%)  1/150 (0.67%)  1/312 (0.32%) 
Musculoskeletal Pain  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Osteoarthritis  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Rheumatoid Arthritis  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon Cancer  1  1/154 (0.65%)  1/150 (0.67%)  0/312 (0.00%) 
B-Cell Lymphoma  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Basal Cell Carcinoma  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Burkitt's Lymphoma  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Cholesteatoma  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Laryngeal Cancer Recurrent  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Lung Carcinoma Cell Type Unspecified Recurrent  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Lung Neoplasm  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Multiple Myeloma  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Myelodysplastic Syndrome  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Neuroendocrine Carcinoma of the Skin  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Small Cell Lung Cancer Stage Unspecified  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Thyroid Cancer  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Nervous system disorders       
Syncope  1  0/154 (0.00%)  0/150 (0.00%)  3/312 (0.96%) 
Cerebral Ischaemia  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Cerebrovascular Accident  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Hypoglycaemic Coma  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Hypotonia  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Loss of Consciousness  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Orthostatic Intolerance  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Vertebrobasilar Insufficiency  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Renal and urinary disorders       
Renal Failure Chronic  1  1/154 (0.65%)  1/150 (0.67%)  6/312 (1.92%) 
Renal Failure  1  1/154 (0.65%)  0/150 (0.00%)  2/312 (0.64%) 
Azotaemia  1  1/154 (0.65%)  0/150 (0.00%)  1/312 (0.32%) 
Nephrotic Syndrome  1  1/154 (0.65%)  1/150 (0.67%)  0/312 (0.00%) 
Renal Failure Acute  1  1/154 (0.65%)  0/150 (0.00%)  1/312 (0.32%) 
Renal Impairment  1  0/154 (0.00%)  0/150 (0.00%)  2/312 (0.64%) 
Cystitis Glandularis  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Haematuria  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Renal Artery Stenosis  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic Obstructive Pulmonary Disease  1  0/154 (0.00%)  2/150 (1.33%)  2/312 (0.64%) 
Pneumonia Aspiration  1  1/154 (0.65%)  0/150 (0.00%)  1/312 (0.32%) 
Acute Respiratory Failure  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Dyspnoea Exertional  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Pulmonary Oedema  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Respiratory Failure  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Skin and subcutaneous tissue disorders       
Diabetic Ulcer  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Drug Eruption  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Pemphigoid  1  1/154 (0.65%)  0/150 (0.00%)  0/312 (0.00%) 
Rash  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Vascular disorders       
Hypertension  1  1/154 (0.65%)  1/150 (0.67%)  3/312 (0.96%) 
Aortic Stenosis  1  1/154 (0.65%)  0/150 (0.00%)  1/312 (0.32%) 
Circulatory Collapse  1  0/154 (0.00%)  0/150 (0.00%)  1/312 (0.32%) 
Haemorrhage  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Hypertensive Crisis  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Peripheral Arterial Occlusive Disease  1  0/154 (0.00%)  1/150 (0.67%)  0/312 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FCM (High Ferritin Target) FCM (Low Ferritin Target) Oral Iron
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   126/154 (81.82%)   129/150 (86.00%)   255/312 (81.73%) 
Blood and lymphatic system disorders       
Anaemia  1  7/154 (4.55%)  8/150 (5.33%)  10/312 (3.21%) 
Gastrointestinal disorders       
Diarrhoea  1  15/154 (9.74%)  11/150 (7.33%)  45/312 (14.42%) 
Constipation  1  2/154 (1.30%)  5/150 (3.33%)  37/312 (11.86%) 
Nausea  1  9/154 (5.84%)  7/150 (4.67%)  15/312 (4.81%) 
Dyspepsia  1  2/154 (1.30%)  3/150 (2.00%)  17/312 (5.45%) 
General disorders       
Oedema Peripheral  1  21/154 (13.64%)  21/150 (14.00%)  29/312 (9.29%) 
Infections and infestations       
Urinary Tract Infection  1  18/154 (11.69%)  10/150 (6.67%)  17/312 (5.45%) 
Nasopharyngitis  1  13/154 (8.44%)  10/150 (6.67%)  16/312 (5.13%) 
Influenza  1  4/154 (2.60%)  8/150 (5.33%)  7/312 (2.24%) 
Musculoskeletal and connective tissue disorders       
Back Pain  1  15/154 (9.74%)  12/150 (8.00%)  11/312 (3.53%) 
Arthralgia  1  10/154 (6.49%)  7/150 (4.67%)  15/312 (4.81%) 
Pain in Extremity  1  2/154 (1.30%)  8/150 (5.33%)  15/312 (4.81%) 
Nervous system disorders       
Dizziness  1  9/154 (5.84%)  8/150 (5.33%)  7/312 (2.24%) 
Headache  1  6/154 (3.90%)  10/150 (6.67%)  7/312 (2.24%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  7/154 (4.55%)  11/150 (7.33%)  11/312 (3.53%) 
Vascular disorders       
Hypertension  1  21/154 (13.64%)  14/150 (9.33%)  32/312 (10.26%) 
Hypotension  1  8/154 (5.19%)  4/150 (2.67%)  5/312 (1.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.1
Initially 1,016 subjects were planned, but due to slow enrollment only 626 were randomised which was sufficient to make the primary comparison between FCM targeting high ferritin level and oral iron.
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.
Investigators may not present or publish partial or complete study results individually. Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information
Organization: Vifor Pharma
Phone: 41 58 851 8222
EMail: medinfo@viforpharma.com
Layout table for additonal information
Responsible Party: Vifor Inc.
ClinicalTrials.gov Identifier: NCT00994318     History of Changes
Other Study ID Numbers: FER-CKD-01
First Submitted: October 12, 2009
First Posted: October 14, 2009
Results First Submitted: April 4, 2014
Results First Posted: May 7, 2014
Last Update Posted: May 20, 2014