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Trial record 20 of 36 for:    pharmacosmos

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose (Provide)

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: NCT02130063
Recruitment Status : Completed
First Posted : May 2, 2014
Results First Posted : May 22, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborators:
BioStata
ClinStar, LLC
LabCorp
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 Iron Deficiency Anaemia
Interventions Drug: iron isomaltoside 1000 (Monofer®)
Drug: iron sucrose (Venofer®)
Enrollment 511
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Hide Arm/Group Description

iron isomaltoside 1000 (Monofer®)

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

iron sucrose (Venofer®)

Period Title: Overall Study
Started 342 169
Completed 317 152
Not Completed 25 17
Arm/Group Title Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®) Total
Hide Arm/Group Description

iron isomaltoside 1000 (Monofer®)

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

iron sucrose (Venofer®)

Total of all reporting groups
Overall Number of Baseline Participants 342 169 511
Hide Baseline Analysis Population Description
FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 342 participants 169 participants 511 participants
49.3  (15.8) 46.8  (14.9) 48.4  (15.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 342 participants 169 participants 511 participants
Female
309
  90.4%
154
  91.1%
463
  90.6%
Male
33
   9.6%
15
   8.9%
48
   9.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 342 participants 169 participants 511 participants
342 169 511
1.Primary Outcome
Title Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5
Hide Description

The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. ‘Any time’ implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder.

Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised.

Time Frame From baseline to week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set (FAS) (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.
Arm/Group Title Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Hide Arm/Group Description:

iron isomaltoside 1000 (Monofer®)

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

iron sucrose (Venofer®)

Overall Number of Participants Analyzed 330 161
Measure Type: Number
Unit of Measure: participants
226 83
2.Secondary Outcome
Title Change in Hb Concentration
Hide Description [Not Specified]
Time Frame From baseline to week 2, 4 and 5
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.
Arm/Group Title Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Hide Arm/Group Description:

iron isomaltoside 1000 (Monofer®)

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

iron sucrose (Venofer®)

Overall Number of Participants Analyzed 330 161
Mean (Standard Deviation)
Unit of Measure: g/dL
Week 2 1.56  (1.03) 0.87  (0.90)
Week 4 2.35  (1.32) 1.74  (1.17)
Week 5 2.52  (1.41) 2.05  (1.27)
3.Secondary Outcome
Title Change in Serum (s)-Ferritin Concentration
Hide Description [Not Specified]
Time Frame From baseline to week 1, 2, 4, and 5
Hide Outcome Measure Data
Hide Analysis Population Description
FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.
Arm/Group Title Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Hide Arm/Group Description:

iron isomaltoside 1000 (Monofer®)

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

iron sucrose (Venofer®)

Overall Number of Participants Analyzed 330 161
Mean (Standard Deviation)
Unit of Measure: ng/mL
Week 1 431.2  (221.4) 86.9  (84.8)
Week 2 516.6  (268.1) 126.2  (87.2)
Week 4 285.3  (205.2) 195.0  (126.2)
Week 5 241.2  (209.3) 185.7  (166.8)
4.Secondary Outcome
Title Change in Transferrin Saturation (TSAT)
Hide Description [Not Specified]
Time Frame From baseline to week 1, 2, 4, and 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Hide Arm/Group Description:

iron isomaltoside 1000 (Monofer®)

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

iron sucrose (Venofer®)

Overall Number of Participants Analyzed 330 161
Mean (Standard Deviation)
Unit of Measure: percent
Week 1 15.7  (9.6) 3.3  (8.1)
Week 2 17.9  (9.8) 5.7  (6.8)
Week 4 16.3  (9.0) 11.5  (9.5)
Week 5 15.6  (8.6) 11.8  (9.5)
Time Frame From screening until week 5
Adverse Event Reporting Description

The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome.

It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.

 
Arm/Group Title Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Hide Arm/Group Description

iron isomaltoside 1000 (Monofer®)

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

iron sucrose (Venofer®)

All-Cause Mortality
Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/333 (0.30%)      0/168 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Iron Isomaltoside 1000 (Monofer®) Iron Sucrose (Venofer®)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/333 (3.30%)      6/168 (3.57%)    
Blood and lymphatic system disorders     
Anaemia   0/333 (0.00%)  0 1/168 (0.60%)  1
Cardiac disorders     
Cardiac failure congestive   1/333 (0.30%)  1 0/168 (0.00%)  0
Cardio-respiratory arrest   1/333 (0.30%)  1 0/168 (0.00%)  0
Ear and labyrinth disorders     
Vertigo positional   0/333 (0.00%)  0 1/168 (0.60%)  1
Gastrointestinal disorders     
Diarrhoea   1/333 (0.30%)  1 0/168 (0.00%)  0
Enteritis   1/333 (0.30%)  1 0/168 (0.00%)  0
Gastric ulcer   1/333 (0.30%)  1 0/168 (0.00%)  0
Gastrointestinal haemorrhage   1/333 (0.30%)  1 0/168 (0.00%)  0
General disorders     
Stent malfunction   0/333 (0.00%)  0 1/168 (0.60%)  1
Immune system disorders     
Anaphylactic reaction   0/333 (0.00%)  0 1/168 (0.60%)  1
Infections and infestations     
Urinary tract infection   1/333 (0.30%)  1 0/168 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Spinal column stenosis   1/333 (0.30%)  1 0/168 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Carcinoid tumour   1/333 (0.30%)  1 0/168 (0.00%)  0
Malignant mediastinal neoplasm   1/333 (0.30%)  1 0/168 (0.00%)  0
Nervous system disorders     
Syncope   1/333 (0.30%)  1 0/168 (0.00%)  0
Vith nerve paralysis   1/333 (0.30%)  1 0/168 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Postpartum haemorrhage   0/333 (0.00%)  0 1/168 (0.60%)  1
Reproductive system and breast disorders     
Haemorrhagic ovarian cyst   1/333 (0.30%)  1 0/168 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma   0/333 (0.00%)  0 1/168 (0.60%)  1
Dyspnoea   1/333 (0.30%)  1 0/168 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash pruritic   1/333 (0.30%)  1 0/168 (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 (Monofer®) Iron Sucrose (Venofer®)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   100/333 (30.03%)      54/168 (32.14%)    
Gastrointestinal disorders     
Nausea   17/333 (5.11%)  19 7/168 (4.17%)  8
Vomiting   7/333 (2.10%)  7 5/168 (2.98%)  6
Diarrhoea   3/333 (0.90%)  3 5/168 (2.98%)  7
General disorders     
Fatique   4/333 (1.20%)  4 5/168 (2.98%)  8
Infections and infestations     
Urinary tract infection   7/333 (2.10%)  7 1/168 (0.60%)  1
Upper respiratory tract infection   4/333 (1.20%)  4 6/168 (3.57%)  6
Musculoskeletal and connective tissue disorders     
Arthralgia   7/333 (2.10%)  9 2/168 (1.19%)  2
Back pain   8/333 (2.40%)  8 2/168 (1.19%)  3
Nervous system disorders     
Dizziness   9/333 (2.70%)  10 4/168 (2.38%)  5
Headache   18/333 (5.41%)  21 11/168 (6.55%)  13
Dysgeusia   2/333 (0.60%)  2 5/168 (2.98%)  10
Skin and subcutaneous tissue disorders     
Rash   14/333 (4.20%)  18 1/168 (0.60%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Chief Medical Officer
Organization: Pharmacosmos
Phone: +45 5948 5959
EMail: llt@pharmacosmos.com
Layout table for additonal information
Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02130063     History of Changes
Other Study ID Numbers: P-Monofer-IDA-01
First Submitted: April 28, 2014
First Posted: May 2, 2014
Results First Submitted: April 26, 2018
Results First Posted: May 22, 2018
Last Update Posted: September 27, 2018