Is functional iron deficiency the cause of anaemia in haemodialysis patients with dialysis catheters? A randomised controlled study

ISRCTN	ISRCTN73108732
DOI	https://doi.org/10.1186/ISRCTN73108732
Protocol serial number	N0436121434
Sponsor	Department of Health (UK)
Funder	Leeds Teaching Hospitals NHS Trust (UK)

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

Dr Paul Laboi
Scientific

Department of Renal Medicine
Wellcome Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Is functional iron deficiency the cause of anaemia in haemodialysis patients with dialysis catheters? A randomised controlled study
Study objectives	To confirm the presence of functional iron deficiency in iron replete haemodialysis patients with dialysis catheters.
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. Treatment one 2. Treatment two
Intervention type	Other
Primary outcome measure(s)	1. To determine the relationship between functional iron deficiency and EPO resistance. 2. Serum ferritin 3. iron 4. transferrin saturation 5. percentage of hypochromic erthrocytes 6. haematocrit 7. reticulocyte count 8. reticulocyte haemoglobin concentration 9. serum C-r
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/10/2003

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Key inclusion criteria	1. Haemodialysis patients over 18 years of age on dialysis treatment for at least 3 months 2. Stable haemodialysis patients dialyzing with a central venous catheter on erythropoietin (EPO) therapy
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/10/2002
Date of final enrolment	01/10/2003

Leeds General Infirmary

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

26/01/2016: no publications found on PubMed.