Predictors of Response to Iron and Erythropoietin Stimulating Agents

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

2015-06-03

Study Completion Date

2017-12-31

Brief Summary

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The purpose of the study is to identify predictors of treatment response. This involves collected baseline clinical parameters and bloods for biochemical parameters prior to administering the study treatment. A positive outcome following treatment was defined as an uptitration of haemoglobin by greater than 5g/l within 2 months. The study evaluated the participants response to treatment against the clinical and biochemical information collected prior to treatment being received.

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Detailed Description

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Conditions

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Renal Failure Chronic Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EPO group

Group Type ACTIVE_COMPARATOR

Epoetin Beta

Intervention Type DRUG

Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000

Iron group

Group Type ACTIVE_COMPARATOR

Iron Sucrose Solution for Injection

Intervention Type DRUG

200mg iron sucrose given on 5 successive haemodialysis sessions

Interventions

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Iron Sucrose Solution for Injection

200mg iron sucrose given on 5 successive haemodialysis sessions

Intervention Type DRUG

Epoetin Beta

Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000

Intervention Type DRUG

Other Intervention Names

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Neorecormon

Eligibility Criteria

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Inclusion Criteria

* All prevalent haemodialysis patients, established for greater than 3 months

Exclusion Criteria

Inability to consent Bone marrow disorder Transfusion dependence Active bleeding Active infection Active malignancy Frail with either frequent hospital admissions or unable to follow trial protocol due to differing target haemoglobin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No