Treatment Response in Dialysis Anaemia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-04-30

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

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Detailed Description

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Conditions

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Anaemia Haemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iron sucrose

Iron sucrose 200mg for 5 doses

Group Type ACTIVE_COMPARATOR

Iron sucrose

Intervention Type DRUG

1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl

Neorecormon

Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000

Group Type ACTIVE_COMPARATOR

Erythopoietin stimulating agent

Intervention Type DRUG

Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria

Interventions

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Iron sucrose

1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl

Intervention Type DRUG

Erythopoietin stimulating agent

Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria

Intervention Type DRUG

Other Intervention Names

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Venofer Neorecormon

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No