Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 36 for:    pharmacosmos

A Randomized, Comparative, Open-label Study of IV Monofer® Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With IV Iron Sucrose in Subjects With CKD-5D

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: NCT01222884
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : July 24, 2015
Last Update Posted : December 2, 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
Condition Chronic Kidney Disease Stage 5 (Dialysis Dependent)
Interventions Drug: Monofer
Drug: Iron sucrose
Enrollment 351
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iron Isomaltoside 1000 Iron Sucrose
Hide Arm/Group Description

Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Period Title: Overall Study
Started 234 117
Completed 210 113
Not Completed 24 4
Arm/Group Title Iron Isomaltoside 1000 Iron Sucrose Total
Hide Arm/Group Description

Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Total of all reporting groups
Overall Number of Baseline Participants 234 117 351
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 117 participants 351 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
129
  55.1%
66
  56.4%
195
  55.6%
>=65 years
105
  44.9%
51
  43.6%
156
  44.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 117 participants 351 participants
60.2  (16.2) 59.5  (15.4) 60.0  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 117 participants 351 participants
Female
76
  32.5%
43
  36.8%
119
  33.9%
Male
158
  67.5%
74
  63.2%
232
  66.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 234 participants 117 participants 351 participants
India 44 28 72
United Kingdom 131 56 187
Russian Federation 6 3 9
Poland 10 3 13
Sweden 6 4 10
Switzerland 13 6 19
Romania 14 12 26
Denmark 6 5 11
United States 4 0 4
1.Primary Outcome
Title Ability to Maintain Hemoglobin Level
Hide Description The primary outcome measure was the proportion of subjects who were able to maintain haemoglobin between 9.5 and 12.5 g/dL (both values included) at week 6. Haemoglobin was measured by a blood sample at the different visits. All blood samples were taken before the dialysis from the dialysis catheter. Intravenous iron was administered during dialysis, at least 30 min after the start and at least 1 h before the end of dialysis.
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.
Arm/Group Title Iron Isomaltoside 1000 Iron Sucrose
Hide Arm/Group Description:

Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Overall Number of Participants Analyzed 226 115
Measure Type: Number
Unit of Measure: percentage of participants
82.7 82.6
2.Secondary Outcome
Title Change in Hemoglobin Concentration
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS population included all subjects who were randomised into the study, received at least one dose of the study drug, and had a Hb assessment. Subjects were included as randomised, regardless of which treatment they actually received.
Arm/Group Title Iron Isomaltoside 1000 Iron Sucrose
Hide Arm/Group Description:

Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

Overall Number of Participants Analyzed 216 113
Mean (Full Range)
Unit of Measure: g/dL
-0.07
(-5.5 to 2.9)
-0.06
(-4.9 to 2.8)
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 Sucrose
Hide Arm/Group Description

Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection

Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics

All-Cause Mortality
Iron Isomaltoside 1000 Iron Sucrose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Iron Isomaltoside 1000 Iron Sucrose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/230 (9.57%)      6/114 (5.26%)    
Cardiac disorders     
acute coronary syndrome   1/230 (0.43%)  1 0/114 (0.00%)  0
acute myocardial infarction   1/230 (0.43%)  1 0/114 (0.00%)  0
Gastrointestinal disorders     
duodenal ulcer haemorrhage   1/230 (0.43%)  1 0/114 (0.00%)  0
gingivalbleeding   1/230 (0.43%)  1 0/114 (0.00%)  0
lower gastrointestinal haemorrhage   1/230 (0.43%)  1 0/114 (0.00%)  0
General disorders     
puncture site haemorrhage   1/230 (0.43%)  1 0/114 (0.00%)  0
sudden death   1/230 (0.43%)  1 0/114 (0.00%)  0
Hepatobiliary disorders     
biliary colic   1/230 (0.43%)  1 0/114 (0.00%)  0
Immune system disorders     
hypersensitivity   1/230 (0.43%)  1 0/114 (0.00%)  0
Infections and infestations     
arteriovenous fistula site infection   1/230 (0.43%)  1 0/114 (0.00%)  0
device related infection   1/230 (0.43%)  1 0/114 (0.00%)  0
infected fistula   1/230 (0.43%)  1 0/114 (0.00%)  0
lower respiratory tract infection   1/230 (0.43%)  1 1/114 (0.88%)  1
respiratory tract infection   1/230 (0.43%)  1 0/114 (0.00%)  0
staphylococcol bacteraimia   0/230 (0.00%)  0 1/114 (0.88%)  1
Injury, poisoning and procedural complications     
fall   3/230 (1.30%)  3 0/114 (0.00%)  0
arteriovenous fistula site haemorrhage   2/230 (0.87%)  2 0/114 (0.00%)  0
femoral neck fracture   1/230 (0.43%)  1 0/114 (0.00%)  0
vascular graft occlusion   1/230 (0.43%)  1 0/114 (0.00%)  0
anaesthetic complication   0/230 (0.00%)  0 1/114 (0.88%)  1
road traffic accident   0/230 (0.00%)  0 1/114 (0.88%)  1
Metabolism and nutrition disorders     
fluid overload   1/230 (0.43%)  1 0/114 (0.00%)  0
Musculoskeletal and connective tissue disorders     
musculoskeletal pain   1/230 (0.43%)  1 0/114 (0.00%)  0
Nervous system disorders     
brain stem infarction   1/230 (0.43%)  1 0/114 (0.00%)  0
Renal and urinary disorders     
nephrolithiasis   1/230 (0.43%)  1 0/114 (0.00%)  0
Reproductive system and breast disorders     
prostatitis   0/230 (0.00%)  0 1/114 (0.88%)  1
Respiratory, thoracic and mediastinal disorders     
dyspnoea   0/230 (0.00%)  0 1/114 (0.88%)  1
Vascular disorders     
aortic stenosis   1/230 (0.43%)  1 0/114 (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 2%
Iron Isomaltoside 1000 Iron Sucrose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/230 (18.26%)      16/114 (14.04%)    
Gastrointestinal disorders     
diarrhoea   5/230 (2.17%)  5 2/114 (1.75%)  2
Infections and infestations     
nasopharyngitis   6/230 (2.61%)  6 1/114 (0.88%)  1
lower respiratory tract infection   4/230 (1.74%)  5 3/114 (2.63%)  4
Injury, poisoning and procedural complications     
fall   7/230 (3.04%)  7 0/114 (0.00%)  0
procedural hypotension   5/230 (2.17%)  18 1/114 (0.88%)  2
Investigations     
C-reactive protein increased   6/230 (2.61%)  6 1/114 (0.88%)  1
Metabolism and nutrition disorders     
hyperphosphataemia   5/230 (2.17%)  5 4/114 (3.51%)  4
Musculoskeletal and connective tissue disorders     
pain in extremity   5/230 (2.17%)  6 0/114 (0.00%)  0
Nervous system disorders     
headache   7/230 (3.04%)  7 4/114 (3.51%)  5
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: NCT01222884     History of Changes
Other Study ID Numbers: P-Monofer-CKD-03
First Submitted: October 15, 2010
First Posted: October 18, 2010
Results First Submitted: June 26, 2015
Results First Posted: July 24, 2015
Last Update Posted: December 2, 2015