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The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPO group | Active Comparator |
| |
| Iron group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Sucrose Solution for Injection | Drug | 200mg iron sucrose given on 5 successive haemodialysis sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin Incrementation | Incrementation of haemoglobin of 5g/l following treatment | Within 2 months |
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Inclusion Criteria:
Exclusion Criteria:
Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin
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| Name | Affiliation | Role |
|---|---|---|
| Damien Ashby, MBBS | Imperial College Healthcare NHS Trust | Principal Investigator |
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No indication to do so
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There were 197 individuals who consented to the study. These were in the observational phase. There were 184 randomisation episodes from these individuals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Group | Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions |
| FG001 | EPO Group | Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This study was analysed on a per protocol rather than intention to treat basis
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Group | Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions |
| BG001 | EPO Group | Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000 |
| 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 | Hemoglobin Incrementation | Incrementation of haemoglobin of 5g/l following treatment | Posted | Count of Participants | Participants | Within 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 Group | Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transfusion | Blood and lymphatic system disorders | MedRA | Systematic Assessment |
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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 |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C103998 | epoetin beta |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Epoetin Beta | Drug | Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000 |
|
|
| Death |
|
| Intercurrent illness |
|
| Transplantation/other operation |
|
| 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 |
|
| Counts |
|---|
| Participants |
|
|
| 3 |
| 88 |
| 17 |
| 88 |
| 2 |
| 88 |
| EG001 | EPO Group | Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000 | 2 | 96 | 21 | 96 | 1 | 96 |
| Cardiac arrhythmia | Cardiac disorders | MedRA | Systematic Assessment | 1 episode of arrhythmia on dialysiand and one episode of atrial fibrillation with fast ventricular rate |
|
| Bacteraemia | Infections and infestations | MedRA | Systematic Assessment |
|
| Soft tissue infection | Skin and subcutaneous tissue disorders | MedRA | Systematic Assessment | 1 diabetic foot and 1 cellulitis |
|
| Cervical discitis | Musculoskeletal and connective tissue disorders | MedRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedRA | Systematic Assessment | Hospital admission due to clinical concern of cardiac event |
|
| Vasculitis | Immune system disorders | MedRA | Systematic Assessment |
|
| Hip fracture | Musculoskeletal and connective tissue disorders | MedRA | Systematic Assessment | Following falls |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedRA | Systematic Assessment |
|
| Infection related to catheters | Infections and infestations | MedRA | Systematic Assessment | Infections related to tunnelled haemodialysis access |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedRA | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedRA | Systematic Assessment |
|
| Psoas abscess | Infections and infestations | MedRA | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedRA | Systematic Assessment |
|
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| 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 |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |