Mean Reticulated Haemoglobin (Hb) Content (RetHe) Analysis of Renal Patients
|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: NCT01126905|
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : November 30, 2018
Anaemia is a common complication of Chronic Kidney Disease (CKD) the management of which has been aided by the use of synthetic recombinant human erythropoietin therapy (r-HuEPO). This red cell stimulating agent creates the further complication of Functional Iron Deficiency (FID) where, despite normal iron stores, patients fail to respond to therapy as they do not possess enough available iron to meet the demand of increased red cell production. Effective response to r-HuEPO therapy depends on an appropriate monitoring of 'available' iron levels.
Previous research into the clinical utility of testing for reticulated haemoglobin concentrations (Ret He) instead of Serum Ferritin and Transferrin Saturation analysis has indicated an advantage as an iron deficient prognostic marker however, further knowledge is required on the use of this new laboratory test (RetHe) to predict Functional Iron Deficiency (FID) level and to study it's relationship with responses to therapy.
This proposed study aims to estimate a local working Normal (non deficient) and Iron Deficient Reticulated Haemoglobin Content (RET He) reference range from surplus anonamous samples. Routine monthly blood samples from Pre Dialysis and Haemodialysis patients will be used to evaluate the sensitivity and specificity of the RET He test compared to current laboratory tests and investigate its predictive ability for Functional Iron Deficiency in these patients.
Studying , measuring and statistically analysing the change in the RET He parameters in Haemodialysis and Pre Dialysis patients over 3 months will look for evidence of a direct relationship between RET He values and the patients response to therapy. The data will be used to provide a predictive picture of what levels of RET He indicate Functional Iron Deficiency.
The introduction of this test (RetHe) may provide clinicians with a one sample/one test control over iron therapies and ensure the patient gets the most benefit from erythropoietin therapy.
|Condition or disease|
|End-Stage Renal Failure Functional Iron Deficiency|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Official Title:||A Local Pilot Evaluation of Laboratory Monitoring of Renal Patients on Erythropoietin and /or Iron Therapy Using Mean Reticulated Haemoglobin Equivalent (RetHe) and Their Response to Therapy|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||October 7, 2010|
|Actual Study Completion Date :||October 7, 2010|
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): NCT01126905
|Study Director:||Raymond Robson||NHS Fife Laboraories|
|Principal Investigator:||PAMELA MARKS, BSc Hons.||NHS Fife Area Laboratory|