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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Anemia
• Kidney Failure, Chronic
• Renal Failure Chronic
• Renal Insufficiency

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