Treatment Response in Dialysis Anaemia

Phase 4

Completed

• Conditions: Anaemia; Haemodialysis
• Interventions: Drug: Erythopoietin stimulating agent; Drug: Iron sucrose

• Registration Number: NCT02707757
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-02-23
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-14
• Primary Completion: 2016-12
• Study Completion: 2017-04
• Results First Submitted: 2021-01-26
• Results First Submitted QC: 2021-02-16
• Status Verified: 2021-03
• Results First Posted: 2021-03-09
• Last Update Submitted: 2021-03-19
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neorecormon	Erythopoietin stimulating agent	Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Iron sucrose	Iron sucrose	Iron sucrose 200mg for 5 doses

Primary Outcome Measures

Name	Time	Method
Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment	2 months

Trial Locations

Locations (2)

Imperial Renal and Transplant Centre; 🇬🇧 London, United Kingdom

Imperial NHS Healthcare Trust; 🇬🇧 London, United Kingdom