Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000189224
Ethics application status
Approved
Date submitted
28/09/2017
Date registered
7/02/2018
Date last updated
7/02/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacist led decision support protocol for the management of anaemia utilising erythrocyte stimulating agents in patients undergoing haemodialysis.
Scientific title
Pharmacist led decision support protocol for the management of anaemia utilising erythrocyte stimulating agents in patients undergoing haemodialysis.
Secondary ID [1] 292985 0
Nil Known
Universal Trial Number (UTN)
U1111-1202-8264
Trial acronym
The PLAM trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
anaemia in renal disease 304889 0
Condition category
Condition code
Renal and Urogenital 304206 304206 0 0
Kidney disease
Blood 304257 304257 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research project is a comparative cohort study of a pharmacist led decision support protocol in anaemia management vs. the current physician based treatment system
Intervention treatment is protocol driven dose adjustment for iron and ESA dose's.
Patients will be dosed with the following medications:
Darbepoetin alfa 10mcg to 200mcg Weekly IV/SC
methoxy polyethylene glycol epoetin beta 30 to 360mcg IV/SC Monthly
Iron Polymaltose 100mg Weekly IV
Iron Sucrose 100mg Weekly IV
Ferric Carboxymaltose 100mg IV weekly
Only ONE type of iron preparation and ONE type of ESA preparation will be used in each patient. The first choice will be iron polymaltose and darbepoetin alfa. patients will only be chaged from iron polymaltose to iron sucrose or ferric carboxymaltose if there was an adverse drug reaction to the iron polymaltose. Methoxy polyethylene glycol epoetin beta will only be used as second line treatment is darbepoetin is considered inappropriate by the nephrologist or as continuation of care for those patients currently being treated with Micera.
The intervention will occur on the dialysis floor in the Hervey Bay Hospital. The trial interventions will occur ONCE a month for 4 months (total of 4 interventions per patient). The mode of delivery will be myself on the computer viewing the monthly bloods. The recommendations will be handed to the RMO on the dialysis unit and the medication changes will be charted on the national inpatient medication chart.
Dose changes will be made on the recommendation set out on the intervention protocol.
For Iron: please see below for the simplified flow chart, and please see the protocol attached to the original ANZCTR registration record for detailed explanation.
If ferritin is <200µg/L or TSAT <20% Start or recommence iron administration
If ferritin is 200-500µg/L and TSAT is 20-40% No change, continue current status.
If ferritin is >500µg/L or TSAT >40% Stop iron administration
If there is conflict between TSAT % and ferritin levels, consult the CNC or Doctor.
For ESA’s: please see the protocol attached to the original ANZCTR registration record for detailed explanation of dose adjustments for ESA’s
Please refer to Darbepoetin dose adjustment tables in the study protocol attached.

Mircera™ methoxy polyethylene glycol-epoetin beta
If Hb increase by <10g/L per month, increase by ~25%, rounded to the nearest convenient formulation.
If Hb target not reached the next month, Increase by another 25%, rounded to the nearest convenient formulation
Please refer to methoxy polyethylene glycol-epoetin beta dose adjustment tables in the study protocol attached.

The intervention will be carried out by myself the Pharmacist. I am a senior pharmacist working in the Renal Unit in Hervey Bay. My Qualifications include Batch. of Pharmaceutical Science (2008) and a Masters of Pharmacy (2009) from Griffith University, and a Graduate Diploma in Clinical Pharmacy from Queens University Belfast, Ireland (2015).
Intervention code [1] 299225 0
Treatment: Other
Comparator / control treatment
Current physician based treatment is the control as post hoc data.
Currently patients being treated by the doctors for dose adjustments for ESA and iron on dialysis.
Control group
Active

Outcomes
Primary outcome [1] 303506 0
Primary outcome will investigate if a pharmacist led decision support protocol in anaemia management will adequately maintain the haemoglobin within the target range. This will be summarised by looking at the target haemoglobin and iron stores for patients on dialysis. Patients are best stabilised with a haemoglobin between 95-115mg/L (9.5-11.5g/DL.
the pathology levels will be assessed via the decision protocol, this will allow the pharmacist to make confident decisions to adjust the patients medication with the doctor.
Timepoint [1] 303506 0
dose adjustment will be made on the first week of each month for a total of 4 months.
Secondary outcome [1] 339120 0
Secondary outcome will measure stability in Ferritin via blood test's as per standard pathology process.
Timepoint [1] 339120 0
4 months post-intervention commencement
Secondary outcome [2] 339240 0
The transferrin saturation % via blood test's as per standard pathology process.
Timepoint [2] 339240 0
4 months post-intervention commencement
Secondary outcome [3] 339898 0
The efficacious use of intravenous iron. Iron is sometimes underutilised, and treatment failure of ESA’s will potentially lead to a loss in Hb secondary to renal disease. This will be assessed with the blood test results, specifically looking at the Ferritin, above 500µg/L
Timepoint [3] 339898 0
4 months post-intervention commencement
Secondary outcome [4] 340305 0
The safe use of erythropoietin stimulating agents (ESA). There is an increased risk of stroke and cardiovascular effects if ESA’s are dosed above the maximum target Hb range. The secondary outcome will assess the potential for adverse effects of ESA’s. Mean values will be assessed comparing the two sites with the use of random effect Poisson models.
Adverse effects from Erythropoietin agonists, Australian Medicines Handbook 2017.
Common (>1%)
hypertension (especially with rapid haemoglobin rise), headache, flu-like symptoms, bone pain, myalgia, fever, rash, hypotension, peripheral oedema, nausea, vomiting, diarrhoea, dyspnoea, thrombotic events, eg thrombosis of vascular access in patients on dialysis, VTE (MI, TIA, stroke are rare), changes in platelet count, local pain (SC; may be more frequent with darbepoetin alfa)
Rare (<0.1%)
hypertensive encephalopathy including seizures, allergy (including angioedema and anaphylactic reactions), pure red cell aplasia (more likely with SC route)
Monitoring will include general observations from the nursing staff as stated on the protocols as attached, and monitoring of monthly blood test results. Please see the protocol attached to the original ANZCTR registration record for detailed explanation.
Timepoint [4] 340305 0
4 months post-intervention commencement
Secondary outcome [5] 340788 0
The safe use of intravenous iron and the efficiency of medication use. Dosing iron efficiently will help to reduce the potential of adverse effects. Blood’s capacity to access and utilise iron can be measured with TSAT%. The blood tests specifically will require TSAT% to between 20-40%.
Timepoint [5] 340788 0
4 months post-intervention commencement

Eligibility
Key inclusion criteria
Inclusion Criteria
Subjects will need to fulfil the following selection criteria.
• Patients must be 18 years old or greater
• Must be diagnosed with End Stage Chronic Kidney Disease (Stage 5) by a Nephrologist
o Study population – CKD dialysis dependent Stage 5 on haemodialysis or home haemodialysis
• Must be established on dialysis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Non-English-speaking personal and those who have been declared medically incompetent to make health care decisions.
• Pregnant or lactating woman.
• Patient who have a known allergy to any ESA’s or intravenous Iron preparations.
• The nephrologist does not feel that the patient is suitable for the program.
• The patient is currently on an ESA dose greater that the recommended maximum of 150mcg of darbepoetin per week or Mircera dose of 360mcg monthly.
• The patient is currently receiving treatment for malignancy with chemotherapy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This research project is a pre-post comparative cohort study of a pharmacist led decision support protocol in anaemia management vs. the current physician based treatment system. The cohort will include dialysis dependent stage 5 chronic kidney disease patients within 3 dialysis units of Fraser Coast renal service (FCRS), within Wide Bay Hospital and Health Service South (WBBHS South). The intervention group will be based in Hervey Bay Hospital (HBH), Maryborough Hospital (MBH) and the Fraser Coast home haemodialysis unit. The current patients being treated in the Fraser Coast renal service will act as their own control. Post hoc data will be collected for four previous months of standard physician based treatment. FCRS mostly use Darbepoetin alfa and Iron polymaltose as part of the current anaemia treatment plan.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis
The comparative nature of the statistical analysis will use a t-test to compare the two arms of the study. The program SPSS will be used to evaluate and statistically analyse the data.
The quantified results will be subject to statistical mathematics with the use of mean, median and Mode. The data will be used to assess changes in haemoglobin, Ferritin and transferrin saturation. A dependent variable t-test will help to identify any statistically significant differences between the 2 arms of data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2018
Actual
Date of last participant enrolment
Anticipated
2/04/2018
Actual
Date of last data collection
Anticipated
31/07/2018
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9113 0
Hervey Bay Hospital - Pialba
Recruitment hospital [2] 9440 0
Maryborough Hospital - Maryborough
Recruitment postcode(s) [1] 18152 0
4650 - Maryborough
Recruitment postcode(s) [2] 18154 0
4655 - Hervey Bay

Funding & Sponsors
Funding source category [1] 297610 0
Hospital
Name [1] 297610 0
Hervey Bay Hosptail
Country [1] 297610 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
20 Cornwall St, Woolloongabba QLD 4102
PACE/UQ School of Pharmacy,
Country
Australia
Secondary sponsor category [1] 296627 0
None
Name [1] 296627 0
Address [1] 296627 0
Country [1] 296627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298702 0
Human Research Ethics Office, Townsville
Ethics committee address [1] 298702 0
Human Research Ethics Committee
The Townsville Hospital and Health Service
Internal Mail Box 52
PO Box 670
Townsville QLD 4810

Townsville Hospital
100 Angus Smith Dr, Douglas QLD 4814
Ethics committee country [1] 298702 0
Australia
Date submitted for ethics approval [1] 298702 0
19/10/2017
Approval date [1] 298702 0
15/12/2017
Ethics approval number [1] 298702 0
HREC/17/QTHS/224

Summary
Brief summary
This research project is a pre-post comparative cohort study of a pharmacist led decision support protocol in anaemia management vs. the current physician based treatment system. The cohort will include dialysis dependent stage 5 chronic kidney disease patients within 3 dialysis units of Fraser Coast renal service (FCRS), within Wide Bay Hospital and Health Service South (WBBHS South). The intervention group will be based in Hervey Bay Hospital (HBH), Maryborough Hospital (MBH) and the Fraser Coast home haemodialysis unit. The current patients being treated in the Fraser Coast renal service will act as their own control. Post hoc data will be collected for four previous months of standard physician based treatment. FCRS mostly use Darbepoetin alfa and Iron polymaltose as part of the current anaemia treatment plan. A t-test will be used to statistically compare the clinical parameters in the two arms of treatment. The main outcomes will be the impact of the pharmacist involvement in optimising anaemia management. This will be summarised by looking at the target haemoglobin and iron stores for the patients. Patients are best stabilised with a haemoglobin between 95-115mg/L (9.5-11.5g/DL). Ferritin targets should maintain between 200-500µg/L and transferrin saturation between 20-40%9,10,11,12,17. A t-test will examine the null hypothesis (H0) comparing the 2 treatment arms.
Primary outcome will investigate if a pharmacist led decision support protocol in anaemia management will adequately maintain the haemoglobin within the target range.
Secondary outcome will measure stability in Ferritin, TSAT%, the appropriate and safe use of iron and erythropoietin stimulating agents (ESA), and the efficiency of medication use.
Aim
The aim of this study is to evaluate the impact of a pharmacist led decision support protocol in anaemia management in a regional haemodialysis unit, using an anaemia management work unit guideline, under the supervision of the consultant nephrologist.
• H0 = The implementation of a pharmacist led decision support protocol in anaemia management service will result in no change in optimising clinical parameters related to iron and Hb compared to the current treatment of a physician based anaemia treatment in dialysis dependent stage 5 kidney disease.
• H1 = The implementation of a pharmacist led decision support protocol in anaemia management will show change in optimising clinical parameters related to iron and Hb compared to the current treatment of a physician based anaemia treatment in dialysis dependent stage 5 kidney disease.
The primary outcome will investigate whether a pharmacist led decision support protocol in anaemia management will adequately maintain the haemoglobin within the target range. This will be summarised by looking at the target haemoglobin and iron stores for patients on dialysis. Patients are best stabilised with a haemoglobin between 95-115mg/L (9.5-11.5g/DL).
Trial website
Trial related presentations / publications
Public notes
the attachment on ANZCTR registration form is all inclusive, protocol, work unit guidelines, patients information and consent forms.
Attachments [1] 2210 2210 0 0
/AnzctrAttachments/373722(v25-11-2017-18-59-55)-44889384_Bermingham.docx (Protocol)

Contacts
Principal investigator
Name 77946 0
Mr Daniel Bermingham
Address 77946 0
Pharmacy Department, Hervey Bay Hospital
Cnr Nissen Street & Urraween Road
Pialba QLD 4655
Country 77946 0
Australia
Phone 77946 0
+61 401351859
Fax 77946 0
+61 7 43256797
Email 77946 0
[email protected]
Contact person for public queries
Name 77947 0
Daniel Bermingham
Address 77947 0
Pharmacy Department, Hervey Bay Hospital
Cnr Nissen Street & Urraween Road
Pialba QLD 4655
Country 77947 0
Australia
Phone 77947 0
+61 401351859
Fax 77947 0
+61 7 43256797
Email 77947 0
[email protected]
Contact person for scientific queries
Name 77948 0
Daniel Bermingham
Address 77948 0
Pharmacy Department, Hervey Bay Hospital
Cnr Nissen Street & Urraween Road
Pialba QLD 4655
Country 77948 0
Australia
Phone 77948 0
+61 401351859
Fax 77948 0
+61 7 43256797
Email 77948 0
[email protected]

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No Supporting Document Provided



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