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OpenTrials
Completed

NCT Number: NCT02707757

Treatment Response in Dialysis Anaemia

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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Key information

Conditions

Anaemia Anemia Haemodialysis Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Imperial NHS Healthcare Trust, London, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron sucrose

Drug

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

Other names: Venofer

Erythopoietin stimulating agent

Drug

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

Other names: Neorecormon

Primary outcomes

  1. Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Official study title

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

Acronym: PRIME

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 14, 2016
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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