Randomised controlled trial of maintaining low serum ferritin levels in patients receiving darbepoetin (Aranesp®)
| ISRCTN | ISRCTN89787518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89787518 |
| Protocol serial number | N0436121433 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 16/08/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R Dedi
Scientific
Scientific
Renal and Liver Services
St James's University Hospital
Beckett Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 243 3144 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Haemodialysis patients are currently treated with intravenous iron and subcutaneous recombinant human erythropoietin to treat anaemia associated with end-stage renal failure. To ensure optimum erythropoiesis, iron stores, as judged by serum ferritin, are kept above the normal range. Recently, a novel form of modified erythropoietin, darbopoetin alfa (Aranesp®), has been licensed for use. This has a longer duration of action and needs to be administered only once a week. Consequently, it does not result in a burst of erythropoietic activity. It is assumed that the prolonged erythropoiesis does not result in peaks of iron utilisation, and so requires lower levels of available iron, which can be replenished from iron stores sufficiently rapidly to continue to support erythropoiesis. We propose to study the effect of maintaining "normal" ferritin levels compared with "supranormal" ferritin in stable haemodialysis patients receiving Aranesp®. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Haemodialysis |
| Intervention | Randomised controlled trial. Random allocation to: 1. Maintenance of normal ferritin 2. Maintenance of elevated ferritin (standard therapy) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Darbepoetin (Aranesp®) |
| Primary outcome measure(s) |
Haemoglobin (g/dl), Darbepoetin (ug/kg/week), Serum Ferritin, Iron Dose (mg/kg/week). Transferrin saturation percentage. C-reactive protein. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Patients will be drawn from the population of haemodialysis patients attending Leeds General Infirmary renal unit. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/2002 |
| Date of final enrolment | 30/11/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Renal and Liver Services
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
