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Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron sucrose | Active Comparator | Iron sucrose 200mg for 5 doses |
|
| Neorecormon | Active Comparator | Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron sucrose | Drug | 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment | 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damien Dr Ashby, MBBS | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial Renal and Transplant Centre | London | W12 0HS | United Kingdom | |||
| Imperial NHS Healthcare Trust |
Recruitment from the study was the prevalent haemodialysis population. Those whom were recruited (197) were then followed until the monthly Hb, taken within routine haemodialysis care, triggered a randomisation event.
Exclusion criteria for either recruitment or a randomisation event:
Overt blood loss Haematological or other malignancy
197 prevalent haemodialysis patients
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Sucrose | Iron sucrose 200mg for 5 doses Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl |
| FG001 | Neorecormon | Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000 Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysed on a per protocol rather than intention to treat basis
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Sucrose | Iron sucrose 200mg for 5 doses Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl |
| BG001 | Neorecormon |
| 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 |
| 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 | Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment | Per protocol analysis | Posted | Count of Participants | Participants | 2 months |
|
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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 Sucrose | Iron sucrose 200mg for 5 doses Iron sucrose: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transfusion | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Damien Ashby | Imperial Healthcare NHS Trust | d.ashby@imperial.ac.uk |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Erythopoietin stimulating agent | Drug | Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria |
|
|
| London |
| United Kingdom |
| Death |
|
| Adverse Event |
|
| Renal transplant/elective operation |
|
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 3 |
| 88 |
| 17 |
| 88 |
| 2 |
| 88 |
| EG001 | Neorecormon | Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000 Erythopoietin stimulating agent: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria | 2 | 96 | 21 | 96 | 1 | 96 |
| Cardiac arrhythmia | Cardiac disorders |
|
| Bacteraemia | Infections and infestations |
|
| Soft tissue infection | Skin and subcutaneous tissue disorders |
|
| Cervical discitis | Musculoskeletal and connective tissue disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Vasculitis | Immune system disorders |
|
| Hip fracture | Musculoskeletal and connective tissue disorders |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders |
|
| Catheter related infection | Infections and infestations |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Psoas abscess | Infections and infestations |
|
| Stroke | Nervous system disorders |
|
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| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |