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Iron Isomaltoside 1000 (Monofer®) in Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia

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ClinicalTrials.gov Identifier: NCT01102413
Recruitment Status : Completed
First Posted : April 13, 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 Iron Deficiency Anemia
Chronic Kidney Disease
Interventions Drug: Monofer
Drug: Iron Sulphate
Enrollment 351
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Monofer Iron Sulphate
Hide Arm/Group Description

Injections or infusions

Monofer: Infusion or injections

Oral intake

Iron Sulphate: Oral intake

Period Title: Overall Study
Started 233 118
Completed 208 106
Not Completed 25 12
Arm/Group Title Monofer Iron Sulphate Total
Hide Arm/Group Description

Injections or infusions

Monofer: Infusion or injections

Oral intake

Iron Sulphate: Oral intake

Total of all reporting groups
Overall Number of Baseline Participants 233 118 351
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 118 participants 351 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
164
  70.4%
80
  67.8%
244
  69.5%
>=65 years
69
  29.6%
38
  32.2%
107
  30.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants 118 participants 351 participants
Female
141
  60.5%
54
  45.8%
195
  55.6%
Male
92
  39.5%
64
  54.2%
156
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 233 participants 118 participants 351 participants
Denmark 13 6 19
Austria 16 5 21
Germany 20 11 31
United Kingdom 19 12 31
India 138 64 202
Poland 4 4 8
Russian Federation 9 8 17
Sweden 1 0 1
United States 13 8 21
1.Primary Outcome
Title Change in Hemoglobin (Hb) Concentration From Baseline to Week 4.
Hide Description [Not Specified]
Time Frame Baseline, 4 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 Monofer Iron Sulphate
Hide Arm/Group Description:

Injections or infusions

Monofer: Infusion or injections

Oral intake

Iron Sulphate: Oral intake

Overall Number of Participants Analyzed 209 108
Mean (Full Range)
Unit of Measure: g/dL
0.57
(-3.1 to 4.0)
0.35
(-3.7 to 3.9)
2.Secondary Outcome
Title Change in Hemoglobin Concentration From Baseline to Week 8
Hide Description [Not Specified]
Time Frame Baseline to week 8
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 Monofer Iron Sulphate
Hide Arm/Group Description:

Injections or infusions

Monofer: Infusion or injections

Oral intake

Iron Sulphate: Oral intake

Overall Number of Participants Analyzed 210 112
Mean (Full Range)
Unit of Measure: g/dL
0.92
(-1.6 to 5.1)
0.45
(-2.9 to 4.0)
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 Monofer Iron Sulphate
Hide Arm/Group Description

Injections or infusions

Monofer: Infusion or injections

Oral intake

Iron Sulphate: Oral intake

All-Cause Mortality
Monofer Iron Sulphate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Monofer Iron Sulphate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/228 (5.26%)      10/117 (8.55%)    
Blood and lymphatic system disorders     
Anaemia   0/228 (0.00%)  0 1/117 (0.85%)  1
Cardiac disorders     
Acute left ventricular failure   0/228 (0.00%)  0 1/117 (0.85%)  1
Cardiac failure   1/228 (0.44%)  1 0/117 (0.00%)  0
Cardiac failure congestive   1/228 (0.44%)  2 0/117 (0.00%)  0
Cardiorenal syndrome   0/228 (0.00%)  0 1/117 (0.85%)  1
Myocardial infarction   1/228 (0.44%)  1 0/117 (0.00%)  0
Ventricular tachycardia   1/228 (0.44%)  1 0/117 (0.00%)  0
Gastrointestinal disorders     
Diarrhoea   1/228 (0.44%)  1 0/117 (0.00%)  0
Gastric ulcer   0/228 (0.00%)  0 1/117 (0.85%)  1
Oesophagitis   0/228 (0.00%)  0 1/117 (0.85%)  1
Hepatobiliary disorders     
Cholangitis   0/228 (0.00%)  0 1/117 (0.85%)  1
Immune system disorders     
Hypersensitivity   2/228 (0.88%)  2 0/117 (0.00%)  0
Infections and infestations     
Plasmodium falciparum infection   1/228 (0.44%)  1 0/117 (0.00%)  0
Pneumonia   2/228 (0.88%)  2 1/117 (0.85%)  1
Pneumonia staphylococcal   0/228 (0.00%)  0 1/117 (0.85%)  1
Urinary track infection   1/228 (0.44%)  1 0/117 (0.00%)  0
Injury, poisoning and procedural complications     
Fall   1/228 (0.44%)  1 0/117 (0.00%)  0
Nervous system disorders     
Carotid artery stenosis   1/228 (0.44%)  1 0/117 (0.00%)  0
Dizziness   1/228 (0.44%)  1 0/117 (0.00%)  0
Polyneuropathy   0/228 (0.00%)  0 1/117 (0.85%)  1
Syncope   0/228 (0.00%)  0 1/117 (0.85%)  1
Renal and urinary disorders     
Renal failure acute   1/228 (0.44%)  1 0/117 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea   1/228 (0.44%)  1 0/117 (0.00%)  0
Vascular disorders     
Hypertension   1/228 (0.44%)  1 0/117 (0.00%)  0
Intermittent claudication   0/228 (0.00%)  0 1/117 (0.85%)  1
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 2%
Monofer Iron Sulphate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   48/228 (21.05%)      22/117 (18.80%)    
Gastrointestinal disorders     
Diarrhoea   6/228 (2.63%)  6 4/117 (3.42%)  4
Faeces discoloured   0/228 (0.00%)  0 5/117 (4.27%)  5
Vomiting   6/228 (2.63%)  7 1/117 (0.85%)  1
General disorders     
Odema peripheral   5/228 (2.19%)  5 2/117 (1.71%)  2
Pyrexia   7/228 (3.07%)  7 4/117 (3.42%)  4
Infections and infestations     
Nasopharyngitis   7/228 (3.07%)  9 4/117 (3.42%)  5
Metabolism and nutrition disorders     
Hyperkalaemia   6/228 (2.63%)  7 0/117 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain   5/228 (2.19%)  5 0/117 (0.00%)  0
Vascular disorders     
Hypertension   6/228 (2.63%)  6 2/117 (1.71%)  2
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 submision for publication.
Results Point of Contact
Name/Title: Vice President Research & Development Department
Organization: Pharmacosmos A/S
Phone: +45 59485959
Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01102413     History of Changes
Other Study ID Numbers: P-Monofer-CKD-02
First Submitted: March 26, 2010
First Posted: April 13, 2010
Results First Submitted: September 21, 2015
Results First Posted: December 3, 2015
Last Update Posted: December 3, 2015