Treatment Response in Dialysis Anaemia

Study Overview
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Brief Summary
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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

Official Title
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Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia

Conditions
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Anaemia, Haemodialysis

Intervention / Treatment
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* Drug: Iron sucrose
* Drug: Erythopoietin stimulating agent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron sucrose<br>Iron sucrose 200mg for 5 doses | Drug: Iron sucrose<br>* 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl<br>* Other names: Venofer;|
| Active Comparator: Neorecormon<br>Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000 | Drug: Erythopoietin stimulating agent<br>* Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria<br>* Other names: Neorecormon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haemodialysis, Anaemia, Iron, Erythropoeitin stimulating agents