Clinical trial NCT01763242: Study of the Effect of Synchronised Anaemia Management in Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure, Chronic
Anemia
Keywords: CKD, Anaemia, Synchronization, Monthly dosing, Home Delivery
Lead sponsor: Western Health, Australia
Sponsor class: OTHER_GOV
First posted: 2013-01-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Haemoglobin
timeFrame: 12 months
Secondary outcomes:
measure: All Cause Hospitalisation
timeFrame: 12 months
measure: Outpatient Review Numbers
timeFrame: 12 months
measure: Primary Care review Numbers
timeFrame: 12 months
measure: Cardiovascular Hospitalisation
timeFrame: 12 months
measure: Cerebrovascular Hospitalisation
timeFrame: 12 months
measure: Peripheral Vascular Hospitalisation
timeFrame: 12 months
measure: Thrombosis Events
timeFrame: 12 months
measure: Renal Replacement Therapy Commencement
timeFrame: 12 months
measure: Deaths
timeFrame: 12 months
measure: Quality of Life
timeFrame: 12 months
measure: Missed Doses of ESA
timeFrame: 12 months
measure: Fe Targets
timeFrame: 12 months
measure: Blood Transfusion Numbers
timeFrame: 12 months
measure: Fe Transfusion Numbers
timeFrame: 12 months
measure: Total Adverse Events
timeFrame: 12 months
measure: Anaemia Co-Ordinator Time
timeFrame: 12 months
measure: Pharmacy Time
timeFrame: 12 months
measure: Courier Costs
timeFrame: 12 months
measure: Ambulance Transfer Numbers
timeFrame: 12 months
measure: Cardiac and Vascular Biomarker Analysis
timeFrame: 12 months
Other outcomes:
measure: Sub-Analysis of Outcomes by ESA Type
timeFrame: 12 months
Locations:
city: Footscray
country: Australia
facility: Western Health
state: Victoria
Study officials:
affiliation: Western Health, Australia
name: Craig L Nelson, MBBSFRACPPhD
role: PRINCIPAL_INVESTIGATOR
References: