Predictors of Response to Iron and Erythropoietin Stimulating Agents

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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Key information

Conditions

Renal Failure Chronic Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Iron Sucrose Solution for Injection

Drug

200mg iron sucrose given on 5 successive haemodialysis sessions

Epoetin beta

Drug

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

Other names: Neorecormon

Primary outcomes

Hemoglobin Incrementation

Time frame: Within 2 months

Incrementation of haemoglobin of 5g/l following treatment

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: PRIME

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Sep 5, 2018
Registry last updated: Jul 5, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed