Phase 4
N=184
Treatment Response in Dialysis Anaemia
Anaemia · Haemodialysis
Bottom Line
View on ClinicalTrials.gov: NCT02707757 ↗Enrolled (actual)
184
Serious AEs
20.7%
Results posted
Mar 2021
Primary outcome: Primary: Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment — 53; 61 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Iron sucrose (Drug); Erythopoietin stimulating agent (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College Healthcare NHS Trust
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment |
53; 61 | — |
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02707757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.