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

Imperial College London

Status and phase: Completed; Phase 4

Conditions: Anemia; Renal Failure Chronic

Treatments: Drug: Epoetin Beta; Drug: Iron Sucrose Solution for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03658876

14HH1987

Details and patient eligibility

About

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.

Enrollment: 197 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 2 patient groups

EPO group

Active Comparator group

Treatment:

Drug: Epoetin Beta

Iron group

Active Comparator group

Treatment:

Drug: Iron Sucrose Solution for Injection