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Treatment Response in Dialysis Anaemia (PRIME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02707757
Recruitment Status : Unknown
Verified March 2016 by Imperial College Healthcare NHS Trust.
Recruitment status was:  Active, not recruiting
First Posted : March 14, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

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

Condition or disease Intervention/treatment Phase
Anaemia Haemodialysis Drug: Iron sucrose Drug: Erythopoietin stimulating agent Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis Iron

Arm Intervention/treatment
Active Comparator: Iron sucrose
Iron sucrose 200mg for 5 doses
Drug: Iron sucrose
1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
Other Name: Venofer

Active Comparator: Neorecormon
Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Drug: Erythopoietin stimulating agent
Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
Other Name: Neorecormon




Primary Outcome Measures :
  1. Increase in haemoglobin by greater than 0.5g/dl [ Time Frame: 2 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707757


Locations
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United Kingdom
Imperial Renal and Transplant Centre
London, United Kingdom, W12 0HS
Imperial NHS Healthcare Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Damien Dr Ashby, MBBS Imperial College Healthcare NHS Trust

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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT02707757    
Other Study ID Numbers: 14HH1987
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: March 2016
Keywords provided by Imperial College Healthcare NHS Trust:
Haemodialysis
Anaemia
Iron
Erythropoeitin stimulating agents
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Iron
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics