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Treatment Response in Dialysis Anaemia (PRIME)

Primary Purpose

Anaemia, Haemodialysis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Iron sucrose
Erythopoietin stimulating agent
Sponsored by
Imperial College Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaemia focused on measuring Haemodialysis, Anaemia, Iron, Erythropoeitin stimulating agents

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Imperial Renal and Transplant Centre
  • Imperial NHS Healthcare Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Iron sucrose

Neorecormon

Arm Description

Iron sucrose 200mg for 5 doses

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2016
Last Updated
March 19, 2021
Sponsor
Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02707757
Brief Title
Treatment Response in Dialysis Anaemia
Acronym
PRIME
Official Title
Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College Healthcare NHS Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaemia, Haemodialysis
Keywords
Haemodialysis, Anaemia, Iron, Erythropoeitin stimulating agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iron sucrose
Arm Type
Active Comparator
Arm Description
Iron sucrose 200mg for 5 doses
Arm Title
Neorecormon
Arm Type
Active Comparator
Arm Description
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Intervention Type
Drug
Intervention Name(s)
Iron sucrose
Other Intervention Name(s)
Venofer
Intervention Description
1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
Intervention Type
Drug
Intervention Name(s)
Erythopoietin stimulating agent
Other Intervention Name(s)
Neorecormon
Intervention Description
Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
Primary Outcome Measure Information:
Title
Haemoglobin Increase of Greater or Equal to 5g/l Following Receipt of Treatment
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Damien Dr Ashby, MBBS
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial Renal and Transplant Centre
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Imperial NHS Healthcare Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Treatment Response in Dialysis Anaemia

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