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Treatment Response in Dialysis Anaemia

NCT02707757 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2021-04-14

Study results available
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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

Conditions

  • Anaemia
  • Haemodialysis

Interventions

DRUG

Iron sucrose

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

DRUG

Erythopoietin stimulating agent

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

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Damien Dr Ashby, MBBS · Imperial College Healthcare NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-12-31
Completion
2017-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02707757 on ClinicalTrials.gov