Treatment Response in Dialysis Anaemia (PRIME)

Imperial College Healthcare NHS Trust

Status and phase

Completed

Phase 4

Conditions

Haemodialysis

Anaemia

Treatments

Drug: Iron sucrose

Drug: Erythopoietin stimulating agent

Study type

Interventional

Funder types

Other

Identifiers

NCT02707757

14HH1987

Details and patient eligibility

About

Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o

Enrollment

197 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

All prevalent haemodialysis patients of the Imperial Renal and Transplant Centre will be eligible for inclusion if they have been on dialysis for more than 3 months

Exclusion criteria

Patients with a bone marrow disorder, active infection or active malignancy will be excluded as these are non-renal causes of anaemia. Patients unable to give informed consent will also not be included within the study.