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A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) as Mono Therapy (Without Erythropoiesis Stimulating Agents) in Comparison With Oral Iron Sulfate in Subjects With Non-myeloid Malignancies Associated With Chemotherapy Induced Anaemia (CIA)

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ClinicalTrials.gov Identifier: NCT01145638
Recruitment Status : Completed
First Posted : June 16, 2010
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-myeloid Malignancies
Chemotherapy Induced Anaemia
Interventions Drug: iron isomaltoside 1000
Drug: iron sulphate
Enrollment 350
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iron Isomaltoside 1000 Iron Sulphate
Hide Arm/Group Description

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Period Title: Overall Study
Started 231 119
Completed 141 62
Not Completed 90 57
Arm/Group Title Iron Isomaltoside 1000 Iron Sulphate Total
Hide Arm/Group Description

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 231 119 350
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 119 participants 350 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
187
  81.0%
101
  84.9%
288
  82.3%
>=65 years
44
  19.0%
18
  15.1%
62
  17.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 119 participants 350 participants
Female
151
  65.4%
90
  75.6%
241
  68.9%
Male
80
  34.6%
29
  24.4%
109
  31.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 231 participants 119 participants 350 participants
India 133 72 205
Germany 7 3 10
Denmark 3 1 4
Spain 2 0 2
Poland 40 16 56
Russian Federation 29 18 47
Sweden 5 3 8
United States 12 6 18
1.Primary Outcome
Title Change in Hb Concentration
Hide Description [Not Specified]
Time Frame Baseline week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.
Arm/Group Title Iron Isomaltoside 1000 Iron Sulphate
Hide Arm/Group Description:

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Overall Number of Participants Analyzed 192 99
Mean (Full Range)
Unit of Measure: g/dL
0.48
(-4 to 4)
0.44
(-2 to 4)
2.Secondary Outcome
Title Change in Hemoglobin From Baseline to Week 24
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all the subjects who were randomised into the study, received at least one dose of the study drug, and had at least one post-baseline Hb assessment. The subjects were considered as randomised, regardless of which treatment they actually received.
Arm/Group Title Iron Isomaltoside 1000 Iron Sulphate
Hide Arm/Group Description:

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

Overall Number of Participants Analyzed 157 72
Mean (Full Range)
Unit of Measure: g/dL
1.60
(-6.3 to 6.5)
1.78
(-5.3 to 7.4)
Time Frame [Not Specified]
Adverse Event Reporting Description The safety population included all subjects who were randomised and received at least one dose of iron isomaltoside 1000 or iron sulphate. The safety analyses was performed on the safety population.
 
Arm/Group Title Iron Isomaltoside 1000 Iron Sulphate
Hide Arm/Group Description

Iron isomaltoside intravenously as bolus or infusion

iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose

oral iron sulphate twice a day

iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks

All-Cause Mortality
Iron Isomaltoside 1000 Iron Sulphate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Iron Isomaltoside 1000 Iron Sulphate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   32/229 (13.97%)      18/112 (16.07%)    
Blood and lymphatic system disorders     
Anaemia   2/229 (0.87%)  2 2/112 (1.79%)  2
Neutropenia   2/229 (0.87%)  2 0/112 (0.00%)  0
Pancytopenia   1/229 (0.44%)  1 1/112 (0.89%)  1
Cardiac disorders     
Atrial fibrillation   3/229 (1.31%)  3 1/112 (0.89%)  1
Cardiac failure   1/229 (0.44%)  1 1/112 (0.89%)  1
Gastrointestinal disorders     
Abdominal pain   1/229 (0.44%)  1 0/112 (0.00%)  0
Ascites   0/229 (0.00%)  0 1/112 (0.89%)  1
Gastrointestinal haemorrhage   1/229 (0.44%)  1 0/112 (0.00%)  0
Gastrointestinal polyp haemorrhage   1/229 (0.44%)  1 0/112 (0.00%)  0
Mouth haemorrhage   1/229 (0.44%)  1 0/112 (0.00%)  0
Stomatitis   1/229 (0.44%)  1 0/112 (0.00%)  0
General disorders     
Asthenia   1/229 (0.44%)  1 1/112 (0.89%)  1
Sudden death   1/229 (0.44%)  1 0/112 (0.00%)  0
Immune system disorders     
Anaphylactic reaction   1/229 (0.44%)  1 0/112 (0.00%)  0
Infections and infestations     
Pneumonia   2/229 (0.87%)  2 0/112 (0.00%)  0
Sepsis   0/229 (0.00%)  0 1/112 (0.89%)  1
Unirary tract infection   0/229 (0.00%)  0 1/112 (0.89%)  1
Injury, poisoning and procedural complications     
Post procedural complication   1/229 (0.44%)  1 0/112 (0.00%)  0
Investigations     
Electrocardiogram abnormal   1/229 (0.44%)  1 0/112 (0.00%)  0
Haemoglobin decreased   1/229 (0.44%)  1 0/112 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration   2/229 (0.87%)  2 0/112 (0.00%)  0
Hyperglycaemia   0/229 (0.00%)  0 1/112 (0.89%)  1
Hypoglycaemia   1/229 (0.44%)  1 0/112 (0.00%)  0
Hyponatraemia   2/229 (0.87%)  2 0/112 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Fistula   1/229 (0.44%)  1 0/112 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression   8/229 (3.49%)  9 7/112 (6.25%)  7
Malignant pleural effusion   0/229 (0.00%)  0 1/112 (0.89%)  1
Metastases to lung   1/229 (0.44%)  1 0/112 (0.00%)  0
Metastases to meninges   0/229 (0.00%)  0 1/112 (0.89%)  2
Nervous system disorders     
Convulsion   0/229 (0.00%)  0 1/112 (0.89%)  1
Headache   0/229 (0.00%)  0 1/112 (0.89%)  1
Transient ischaemic attack   1/229 (0.44%)  1 0/112 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia   1/229 (0.44%)  1 0/112 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure   1/229 (0.44%)  1 0/112 (0.00%)  0
Dyspnoe   1/229 (0.44%)  1 0/112 (0.00%)  0
Epistaxis   0/229 (0.00%)  0 1/112 (0.89%)  1
Pneumonia aspiration   1/229 (0.44%)  1 0/112 (0.00%)  0
Pneumothorax   0/229 (0.00%)  0 1/112 (0.89%)  1
Respiratory distress   0/229 (0.00%)  0 1/112 (0.89%)  1
Stridor   1/229 (0.44%)  1 0/112 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Iron Isomaltoside 1000 Iron Sulphate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   173/229 (75.55%)      107/112 (95.54%)    
Blood and lymphatic system disorders     
Anaemia   20/229 (8.73%)  22 12/112 (10.71%)  13
Leukopenia   12/229 (5.24%)  13 10/112 (8.93%)  13
Neutropenia   15/229 (6.55%)  21 6/112 (5.36%)  9
Thrombocytopenia   11/229 (4.80%)  13 7/112 (6.25%)  11
Gastrointestinal disorders     
Constipation   7/229 (3.06%)  8 7/112 (6.25%)  7
Diarrhoea   8/229 (3.49%)  14 10/112 (8.93%)  11
Faeces discoloured   1/229 (0.44%)  1 9/112 (8.04%)  9
Nausea   14/229 (6.11%)  19 8/112 (7.14%)  12
Stomatitis   14/229 (6.11%)  14 5/112 (4.46%)  5
Vomiting   16/229 (6.99%)  24 7/112 (6.25%)  8
General disorders     
Asthenia   18/229 (7.86%)  20 7/112 (6.25%)  9
Pyrexia   12/229 (5.24%)  13 4/112 (3.57%)  4
Metabolism and nutrition disorders     
Decreased appetite   8/229 (3.49%)  8 6/112 (5.36%)  6
Skin and subcutaneous tissue disorders     
Alopecia   17/229 (7.42%)  17 9/112 (8.04%)  9
Indicates events were collected by systematic assessment
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.
If Pharmacosmos or its agents has not prepared a draft for submission to a peer reviewed journal prior to 1 year following completion of the study report, the investigators have the right to publish the results. Such publications are to be submitted to Pharmacosmos for comment 30 days prior to submission for publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President Research & Development Department
Organization: Pharmacosmos A/S
Phone: +45 59485959
EMail: llt@pharmacosmos.com
Layout table for additonal information
Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01145638     History of Changes
Other Study ID Numbers: P-Monofer-CIA-01
EudraCT no. 2009-016727-53
First Submitted: June 15, 2010
First Posted: June 16, 2010
Results First Submitted: September 21, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015