Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease

Anemia Clinical Trial

— EMAN-Anaemia  

Official title:

EMAN-Anaemia: An Open Labelled Randomised Control Trial of the Synchronized Electronic MANagement of Anaemia in Chronic Kidney Disease (CKD) Compared to Usual Care Anaemia Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01763242
• Other study ID #: HREC: 2010.267
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2013
• Last updated: January 6, 2013
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Western Health, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Aims:

1. To establish an electronic process for CKD anaemia management using monthly synchronized dosing of erythrocyte stimulating agents (ESA).

2. To compare this electronic process with "present anaemia management" in the traditional outpatient setting.

3. To monitor Hb targets and clinical endpoints of study groups to model a larger multicentre study focusing on these endpoints.

Description:

CKD Stages 3 to 5 Subjects will be randomised and stratified according to Age, Gender, CKD Stage, Known Cardiovascular Disease, Diabetes and ESA Type into EMAN vs. Control

Details of EMAN synchronization and Dosing:

Monthly dose of ESA is calculated by:

Monthly dose = present dose x (28/present frequency (days))

Synchronization will be achieved by using the formula: "Synchronization dose of ESA = (28-Days until next injection is due)/28 x monthly dose of ESA

The dose of ESA/C.E.R.A. should be adjusted to maintain the individual patient's haemoglobin within a range of 11± 1.0 g/dL of the reference haemoglobin concentration ie. between 10.0 and 12.0 g/dL

Haemoglobin Value Corrective Adjustment

• A single value >13 g/dL Interrupt treatment until Hb falls below 12 g/dL then re-start treatment at 50% of previous dose

• A single value <9 g/dL Increase dose by 50%

• Difference between two consecutive Hb values indicates ≥2 g/dL increase Reduce dose by 50%

• Difference between two consecutive Hb values indicates ≥2 g/dL decrease Increase dose by 50%

• >11.5 g/dL and <13 g/dL AND deviation from reference value is >1g/dL. Reduce dose by 25%

• <10.5 g/dL and >9 g/dL AND deviation from reference value is >1g/dL. Increase dose by 25%

• >12 g/dL Reduce dose by 25%

• <10 g/dL Increase dose by 25%

Statistics:

Audit of present practice suggests CKD patients achieve only 30% on target (Hb 10-12g/dL) while well audited dialysis units in our service can achieve 60% at target.

If an improvement from 30% to 60% is expected in the EMAN verses Control arm then 100 patients (50 in each group) would be required to show a significant difference p<0.05 with 85% power.

Patients will be analysed on an intention to treat basis Primary and Secondary Endpoint data will be compared between study and control groups using unpaired student t-tests after normalisation of data as required and/or chi squared analysis.

Statistical significance will be taken at p<0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Age > 18 years

• Chronic renal anaemia already on ESA therapy as defined by Pharmaceutical Benefits Scheme Criteria

Exclusion Criteria:

• Pregnancy

• Significant acute bleeding such as overt gastrointestinal bleeding

• A known haematological cause for anaemia

• Known metastatic malignancy

• Present participation in another interventional clinical trial • Known hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• EMAN
See details on ESA Synchronization and Dosing in Detailed Description Above

Locations

Country	Name	City	State
Australia	Western Health	Footscray	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Western Health, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sub-Analysis of Outcomes by ESA Type		12 months	Yes
Primary	Haemoglobin	Haemoglobin (Hb) Targets: % above/within/below target ; % Time Hb above/within/below Target ie. Hb 10 to 12g/dL.	12 months	Yes
Secondary	All Cause Hospitalisation	Same day and Non Same Day Hospitalisation analysis, Total Hospitalisations	12 months	Yes
Secondary	Outpatient Review Numbers		12 months	No
Secondary	Primary Care review Numbers		12 months	No
Secondary	Cardiovascular Hospitalisation		12 months	Yes
Secondary	Cerebrovascular Hospitalisation		12 months	Yes
Secondary	Peripheral Vascular Hospitalisation		12 months	Yes
Secondary	Thrombosis Events	Venous and Arterial	12 months	Yes
Secondary	Renal Replacement Therapy Commencement	Dialysis and Renal transplantation	12 months	Yes
Secondary	Deaths		12 months	Yes
Secondary	Quality of Life		12 months	Yes
Secondary	Missed Doses of ESA		12 months	Yes
Secondary	Fe Targets		12 months	Yes
Secondary	Blood Transfusion Numbers		12 months	Yes
Secondary	Fe Transfusion Numbers		12 months	Yes
Secondary	Total Adverse Events		12 months	Yes
Secondary	Anaemia Co-Ordinator Time		12 months	No
Secondary	Pharmacy Time		12 months	No
Secondary	Courier Costs		12 months	No
Secondary	Ambulance Transfer Numbers		12 months	No
Secondary	Cardiac and Vascular Biomarker Analysis	N Terminal Pro-Brain Natruretic Peptide, Interleukin-6, Tumour Necrosis Factor alpha, High Sensitivity C Reactive Protein	12 months	Yes