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)
![]() |
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: NCT01145638 |
Recruitment Status :
Completed
First Posted : June 16, 2010
Results First Posted : December 3, 2015
Last Update Posted : December 3, 2015
|
Sponsor:
Pharmacosmos A/S
Information provided by (Responsible Party):
Pharmacosmos A/S
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Iron Isomaltoside 1000 | Iron Sulphate |
---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | Iron Isomaltoside 1000 | Iron Sulphate | Total | |
---|---|---|---|---|
![]() |
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 | |
![]() |
[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 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
Name/Title: | Vice President Research & Development Department |
Organization: | Pharmacosmos A/S |
Phone: | +45 59485959 |
EMail: | llt@pharmacosmos.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Pharmacosmos A/S |
ClinicalTrials.gov Identifier: | NCT01145638 |
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 |