Anaemia, Haemodialysis
Conditions
Keywords
Haemodialysis, Anaemia, Iron, Erythropoeitin stimulating agents
Brief summary
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
Interventions
DRUGIron sucrose
1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
DRUGErythopoietin stimulating agent
Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
Sponsors
Imperial College Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months
Exclusion criteria
* Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment | 2 months |
Countries
United Kingdom
Participant flow
Recruitment details
197 prevalent haemodialysis patients
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 76 |
| 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 | 84 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Renal transplant/elective operation | 1 | 5 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Iron Sucrose | Neorecormon | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 43 Participants | 82 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 41 Participants | 78 Participants |
| Age, Continuous | 63.22 years | 63.10 years | 63.16 years |
| Race/Ethnicity, Customized Ethnicity Asian | 31 Participants | 28 Participants | 59 Participants |
| Race/Ethnicity, Customized Ethnicity Black | 9 Participants | 12 Participants | 21 Participants |
| Race/Ethnicity, Customized Ethnicity Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Ethnicity White | 34 Participants | 41 Participants | 75 Participants |
| Region of Enrollment United Kingdom | 76 participants | 84 participants | 160 participants |
| Sex: Female, Male Female | 22 Participants | 24 Participants | 46 Participants |
| Sex: Female, Male Male | 54 Participants | 60 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 88 | 2 / 96 |
| other Total, other adverse events | 2 / 88 | 1 / 96 |
| serious Total, serious adverse events | 17 / 88 | 21 / 96 |
Outcome results
Primary
Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
Time frame: 2 months
Population: Per protocol analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iron Sucrose | Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment | 53 Participants |
| Neorecormon | Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment | 61 Participants |