Predictors of Response to Iron and Erythropoietin Stimulating Agents (PRIME)

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.

Study Overview

• Status: Completed
• Conditions: Anemia; Renal Failure Chronic
• Intervention / Treatment: Drug: Epoetin Beta; Drug: Iron Sucrose Solution for Injection

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EPO group	Drug: Epoetin Beta; Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000; Other Names: Neorecormon
Active Comparator: Iron group	Drug: Iron Sucrose Solution for Injection; 200mg iron sucrose given on 5 successive haemodialysis sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin Incrementation	Incrementation of haemoglobin of 5g/l following treatment	Within 2 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Damien Ashby, MBBS, Imperial College Healthcare NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2015
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Hemodialysis
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Hematinics; Ferric Oxide, Saccharated
• Other Study ID Numbers: 14HH1987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No indication to do so

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No