Treatment Response in Dialysis Anaemia

NCT02707757 | Completed Phase 4 Results DMC

• 1 other identifier: 14HH1987
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Anaemia; Haemodialysis

Keywords

Haemodialysis; Anaemia; Iron; Erythropoeitin stimulating agents

Outcome Measures

Primary Outcomes (1)

• Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment

  2 months

Study Arms (2)

Iron sucrose

ACTIVE COMPARATOR

Iron sucrose 200mg for 5 doses

Drug: Iron sucrose

Neorecormon

ACTIVE COMPARATOR

Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000

Drug: Erythopoietin stimulating agent

Interventions

Iron sucrose DRUG

1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl

Also known as: Venofer

Iron sucrose

Erythopoietin stimulating agent DRUG

Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria

Also known as: Neorecormon

Neorecormon

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College Healthcare NHS Trust: lead

Study Sites (2)

Imperial Renal and Transplant Centre

London, W12 0HS, United Kingdom

Location

Imperial NHS Healthcare Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Anemia

Interventions

Ferric Oxide, Saccharated; epoetin beta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Dr Damien Ashby
• Organization: Imperial Healthcare NHS Trust

d.ashby@imperial.ac.uk

Study Officials

• Damien Dr Ashby, MBBS

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 14, 2016
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 14, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-03

Locations

GB (2)