Treatment Response in Dialysis Anaemia

Anaemia Clinical Trial

— PRIME  

Official title:

Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707757
• Other study ID #: 14HH1987
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: April 2017

Study information

• Verified date: March 2021
• Source: Imperial College Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: April 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Haemodialysis

Intervention

Drug:
• Iron sucrose
1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
• Erythopoietin stimulating agent
Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria

Locations

Country	Name	City	State
United Kingdom	Imperial NHS Healthcare Trust	London
United Kingdom	Imperial Renal and Transplant Centre	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment		2 months