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

Primary Purpose

Renal Failure Chronic, Anemia

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Iron Sucrose Solution for Injection
Epoetin Beta
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Renal Failure Chronic focused on measuring Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    EPO group

    Iron group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Hemoglobin Incrementation
    Incrementation of haemoglobin of 5g/l following treatment

    Secondary Outcome Measures

    Full Information

    First Posted
    August 30, 2018
    Last Updated
    June 27, 2019
    Sponsor
    Imperial College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03658876
    Brief Title
    Predictors of Response to Iron and Erythropoietin Stimulating Agents
    Acronym
    PRIME
    Official Title
    Predictors of Response to Iron and Erythropoietin Stimulating Agents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 3, 2015 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperial College London

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Failure Chronic, Anemia
    Keywords
    Hemodialysis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    197 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    EPO group
    Arm Type
    Active Comparator
    Arm Title
    Iron group
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Iron Sucrose Solution for Injection
    Intervention Description
    200mg iron sucrose given on 5 successive haemodialysis sessions
    Intervention Type
    Drug
    Intervention Name(s)
    Epoetin Beta
    Other Intervention Name(s)
    Neorecormon
    Intervention Description
    Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
    Primary Outcome Measure Information:
    Title
    Hemoglobin Incrementation
    Description
    Incrementation of haemoglobin of 5g/l following treatment
    Time Frame
    Within 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Damien Ashby, MBBS
    Organizational Affiliation
    Imperial College Healthcare NHS Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No indication to do so

    Learn more about this trial

    Predictors of Response to Iron and Erythropoietin Stimulating Agents

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