Anemia, Renal Failure Chronic
Conditions
Keywords
Hemodialysis
Brief summary
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.
Interventions
200mg iron sucrose given on 5 successive haemodialysis sessions
DRUGEpoetin Beta
Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All prevalent haemodialysis patients, established for greater than 3 months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Incrementation | Within 2 months | Incrementation of haemoglobin of 5g/l following treatment |
Participant flow
Pre-assignment details
There were 197 individuals who consented to the study. These were in the observational phase. There were 184 randomisation episodes from these individuals.
Participants by arm
| Arm | Count |
|---|---|
| Iron Group Iron Sucrose Solution for Injection: 200mg iron sucrose given on 5 successive haemodialysis sessions | 76 |
| EPO Group Epoetin Beta: Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000 | 84 |
| Total | 160 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Intercurrent illness | 6 | 4 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Transplantation/other operation | 1 | 5 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Iron Group | EPO Group | 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 | 63.1 years | 63.16 years |
| Race/Ethnicity, Customized Asian | 31 Participants | 28 Participants | 59 Participants |
| Race/Ethnicity, Customized Black | 9 Participants | 12 Participants | 21 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized 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
Hemoglobin Incrementation
Incrementation of haemoglobin of 5g/l following treatment
Time frame: Within 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EPO Group | Hemoglobin Incrementation | 61 Participants |
| Iron Group | Hemoglobin Incrementation | 53 Participants |