|
ISRCTN
|
ISRCTN89787518
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Randomised controlled trial of maintaining low serum ferritin levels in patients receiving darbepoetin (Aranesp®)
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0436121433
|
|
Study hypothesis
|
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®.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Haemodialysis
|
|
Participants - inclusion criteria
|
Patients will be drawn from the population of haemodialysis patients attending Leeds General Infirmary renal unit.
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/11/2002
|
|
Anticipated end date
|
30/11/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
Randomised controlled trial. Random allocation to:
1. Maintenance of normal ferritin
2. Maintenance of elevated ferritin (standard therapy)
|
|
Primary outcome measure(s)
|
Haemoglobin (g/dl), Darbepoetin (ug/kg/week), Serum Ferritin, Iron Dose (mg/kg/week). Transferrin saturation percentage. C-reactive protein.
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Leeds Teaching Hospitals NHS Trust (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
R
Dedi
|
|
Address
|
Renal and Liver Services
St James's University Hospital
Beckett Street
|
|
City/town
|
Leeds
|
|
Zip/Postcode
|
LS1 3EX
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)113 243 3144
|
|
Fax
|
+44 (0)113 242 6496
|
|
Email
|
comdhfo@stjames.leeds.ac.uk
|
|
Sponsor
|
Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
|
|
Address
|
The Department of Health
Richmond House
79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)207 307 2622
|
|
Fax
|
+44 (0)207 307 2623
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.doh.gov.uk
|
|
Date applied
|
12/09/2003
|
|
Last edited
|
28/09/2009
|
|
Date ISRCTN assigned
|
12/09/2003
|
