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The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron isomaltoside 1000 | Active Comparator | Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection |
|
| Iron sucrose | Active Comparator | Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monofer | Drug | Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability to Maintain Hemoglobin Level | 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. | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration | 6 weeks |
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Inclusion Criteria:
Subjects with a diagnosis of CKD-5D, in dialysis therapy for at least 90 days prior to inclusion, will be included if they meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Lykke Thomsen, MD | Pharmacosmos A/S | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jatin Kothari | Mumbai | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Isomaltoside 1000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Iron sucrose | Drug | 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 |
|
| Iron Sucrose |
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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Isomaltoside 1000 | 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 |
| BG001 | Iron Sucrose | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ability to Maintain Hemoglobin Level | 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. | 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. | Posted | Number | percentage of participants | Baseline to 6 weeks |
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| Secondary | Change in Hemoglobin Concentration | 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. | Posted | Mean | Full Range | g/dL | 6 weeks |
|
|
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iron Isomaltoside 1000 | 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 | 22 | 230 | 42 | 230 | ||
| EG001 | Iron Sucrose | 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 | 6 | 114 | 16 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| acute coronary syndrome | Cardiac disorders | Systematic Assessment |
| ||
| acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| duodenal ulcer haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| gingivalbleeding | Gastrointestinal disorders | Systematic Assessment |
| ||
| lower gastrointestinal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| puncture site haemorrhage | General disorders | Systematic Assessment |
| ||
| sudden death | General disorders | Systematic Assessment |
| ||
| biliary colic | Hepatobiliary disorders | Systematic Assessment |
| ||
| hypersensitivity | Immune system disorders | Systematic Assessment |
| ||
| arteriovenous fistula site infection | Infections and infestations | Systematic Assessment |
| ||
| device related infection | Infections and infestations | Systematic Assessment |
| ||
| infected fistula | Infections and infestations | Systematic Assessment |
| ||
| lower respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| staphylococcol bacteraimia | Infections and infestations | Systematic Assessment |
| ||
| fall | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
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| femoral neck fracture | Injury, poisoning and procedural complications | Systematic Assessment |
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| vascular graft occlusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| anaesthetic complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
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| musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| brain stem infarction | Nervous system disorders | Systematic Assessment |
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| nephrolithiasis | Renal and urinary disorders | Systematic Assessment |
| ||
| prostatitis | Reproductive system and breast disorders | Systematic Assessment |
| ||
| dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| aortic stenosis | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| lower respiratory tract infection | Infections and infestations | Systematic Assessment |
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| fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| procedural hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
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| C-reactive protein increased | Investigations | Systematic Assessment |
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| hyperphosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
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| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| headache | Nervous system disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Research & Development Department | Pharmacosmos A/S | +45 59485959 | llt@pharmacosmos.com |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
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| >=65 years |
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| Male |
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| United Kingdom |
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| Russian Federation |
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| Poland |
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| Sweden |
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| Switzerland |
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| Romania |
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| Denmark |
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| United States |
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