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NCT03658876 Clinical Trial

Predictors of Response to Iron and Erythropoietin Stimulating Agents

Anemia Clinical Trial

— PRIME  

Official title:
Predictors of Response to Iron and Erythropoietin Stimulating Agents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03658876
Other study ID # 14HH1987
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date June 3, 2015
Est. completion date December 31, 2017

Study information
Verified date June 2019
Source Imperial College London
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 197
Est. completion date December 31, 2017
Est. primary completion date December 31, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Iron Sucrose Solution for Injection
200mg iron sucrose given on 5 successive haemodialysis sessions
• Epoetin Beta
Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Imperial College London

Outcome
Type Measure Description Time frame Safety issue
Primary Hemoglobin Incrementation Incrementation of haemoglobin of 5g/l following treatment Within 2 months
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