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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03658876
Recruitment Status : Completed
First Posted : September 5, 2018
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

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.

Condition or disease Intervention/treatment Phase
Renal Failure Chronic Anemia Drug: Iron Sucrose Solution for Injection Drug: Epoetin Beta Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Predictors of Response to Iron and Erythropoietin Stimulating Agents
Actual Study Start Date : June 3, 2015
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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 Name: Neorecormon

Active Comparator: Iron group Drug: Iron Sucrose Solution for Injection
200mg iron sucrose given on 5 successive haemodialysis sessions




Primary Outcome Measures :
  1. Hemoglobin Incrementation [ Time Frame: Within 2 months ]
    Incrementation of haemoglobin of 5g/l following treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03658876


Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Damien Ashby, MBBS Imperial College Healthcare NHS Trust

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03658876     History of Changes
Other Study ID Numbers: 14HH1987
First Posted: September 5, 2018    Key Record Dates
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No indication to do so

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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
Keywords provided by Imperial College London:
Hemodialysis
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Iron
Epoetin Alfa
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics