Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000432213
Ethics application status
Approved
Date submitted
10/06/2009
Date registered
10/06/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial)
Scientific title
A randomised controlled trial of oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial)
Secondary ID [1] 895 0
Cochrane Renal Group Registry number CRG110600094.
Universal Trial Number (UTN)
Trial acronym
The HEMATOCRIT trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron deficiency anaemia 236944 0
Condition category
Condition code
Renal and Urogenital 237295 237295 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of oral Heme Iron Polypeptide [HIP; Proferrin (Registered trademark) ES, Colorado Biolabs, USA] 12mg (1 tablet) twice daily for 6 months
Intervention code [1] 236724 0
Treatment: Drugs
Comparator / control treatment
Administration of oral slow-release ferrous sulphate [Ferrogradumet (Registered Trademark), Abbott, Sydney, Australia] 325mg (1 tablet) twice daily for 6 months
Control group
Active

Outcomes
Primary outcome [1] 238105 0
Transferrin saturation (TSAT) values measured via blood analysis
Timepoint [1] 238105 0
At baseline then every 2 months for 6 months
Secondary outcome [1] 242313 0
Serum ferritin concentrations measured via blood analysis
Timepoint [1] 242313 0
At baseline then every 2 months for 6 months
Secondary outcome [2] 242314 0
Haemoglobin levels measured via blood analysis
Timepoint [2] 242314 0
At baseline then every month for 6 months
Secondary outcome [3] 242315 0
Prescribed dosages of darbepoietin alpha [DPO; Aranesp(Registered trademark) Amgen]. Study participants will be questioned regarding DPO dosage at each 2nd monthly clinical review.
Timepoint [3] 242315 0
At baseline then every 2 months for 6 months
Secondary outcome [4] 242316 0
Key's index (DPO dosage divided by haemoglobin concentration). Study participants will be questioned regarding DPO dosage at each 2nd monthly clinical review. Haemoglobin concentration will be measured via blood analysis.
Timepoint [4] 242316 0
At baseline then every 2 months for 6 months
Secondary outcome [5] 242317 0
Significant side effects. Study participants will questioned at each 2nd monthly clinical review as to whether they have encountered any problems with the trial medication. They will also be specifically questioned regarding whether they have experienced any gastrointestinal side effects (nausea, vomiting, altered bowel habit).
Timepoint [5] 242317 0
Every 2 months for 6 months

Eligibility
Key inclusion criteria
1. On peritoneal dialysis for 1 month or longer.
2. On DPO for 1 month or longer.
3. 18 years or over.
4. Able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study.
2. Pregnancy or breast-feeding.
3. Known hypersensitivity to, or intolerance of, oral iron, HIP or DPO.
4. Active peptic ulcer disease.
5. Vitamin B12 or folate deficiency.
6. Recent (within 1 month) acute infection.
7. Parathyroid hormone level > 100 pmol/L.
8. Serum aluminium > 2 micromol/L.
9. Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy
10. Major surgery, infection, acute myocardial infarction or malignancy within the last 3 months.
11. Intravenous iron therapy, vitamin C therapy, melatonin treatment, androgen therapy or blood transfusion within the previous month.
12. Serum ferritin 500 microgram/mL or greater or transferrin saturation (TSAT) 50% or greater.
13. Religious or other objection to consuming product prepared from bovine blood.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be performed using sequentially numbered, opaque, sealed envelopes, stratified for the presence or absence of a TSAT less than or equal to 20%.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of interventions was obtained from a computer-generated random number list in permuted blocks provided through the Australasian Kidney Trials (AKTN) network.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237122 0
Commercial sector/Industry
Name [1] 237122 0
Amgen Australia Pty. Ltd.
Country [1] 237122 0
Australia
Primary sponsor type
Individual
Name
Professor David Johnson
Address
Department of Nephrology
Level 2 ARTS building
Princess Alexandra Hospital
199 Ipswich Rd
Woollongabba 4102
Victoria
Country
Australia
Secondary sponsor category [1] 4615 0
Individual
Name [1] 4615 0
Dr. Katherine Barraclough
Address [1] 4615 0
Department of Nephrology
Level 2 ARTS building
Princess Alexandra Hospital
199 Ipswich Rd
Woollongabba 4102
Victoria
Country [1] 4615 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239217 0
Princess Alexandra Human Reseach Ethics Committee
Ethics committee address [1] 239217 0
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba 4102
QLD
Ethics committee country [1] 239217 0
Australia
Date submitted for ethics approval [1] 239217 0
Approval date [1] 239217 0
15/11/2006
Ethics approval number [1] 239217 0
2006/144
Ethics committee name [2] 239218 0
West Moreton South Burnett Health Service District Human Ethics Committee
Ethics committee address [2] 239218 0
Ipswich Hospital
Chelmsford Avenue
Ipswich Qld 4305
Ethics committee country [2] 239218 0
Australia
Date submitted for ethics approval [2] 239218 0
Approval date [2] 239218 0
10/10/2007
Ethics approval number [2] 239218 0
4/08/2009

Summary
Brief summary
The main hypothesis of the study is that Heme Iron Polypeptide [HIP; Proferrin (registered trademark) ES] administration will more effectively augment iron stores in erythropoeitin stimulating agent-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation [Ferrogradumet (Registered Trademark)]. Patients will be randomized to receive either slow-release ferrous sulphate (1 tablet twice daily; control) or HIP (1 tablet twice daily) orally for a period of 6 months. The study will follow an open-label design but outcome assessors will be blinded to study treatment. During this 6 month study period, haemoglobin levels will be measured monthly and iron studies (including transferring saturation [TSAT] measurements) will be performed bi-monthly (as per usual clinical practice). Patients will be reviewed by PD nursing staff monthly and by nephrologists bi-monthly (as per usual clinical practice). The primary outcome measure will be the difference in TSAT levels between the 2 groups at the end of the 6 month study period, adjusted for baseline values using analysis of covariance. Secondary outcome measures will include serum ferritin concentration, haemoglobin level, darbapoeitin dosage, Key’s index (darbapoetin dosage divided by haemoglobin concentration), and occurrence of adverse events (especially gastrointestinal adverse events).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29713 0
Address 29713 0
Country 29713 0
Phone 29713 0
Fax 29713 0
Email 29713 0
Contact person for public queries
Name 12960 0
Dr Katherine Barraclough
Address 12960 0
Level 2 ARTS building
Princess ALexandra Hospital
199 Ipswich Road
Woolloongabba
4102 QLD
Country 12960 0
Australia
Phone 12960 0
+61 7 3240 5080
Fax 12960 0
Email 12960 0
katherine_barraclough@health.qld.gov.au
Contact person for scientific queries
Name 3888 0
Professor David Johson
Address 3888 0
Level 2 ARTS building
Princess ALexandra Hospital
199 Ipswich Road
Woolloongabba
4102 QLD
Country 3888 0
Australia
Phone 3888 0
+61 7 3240 5080
Fax 3888 0
Email 3888 0
david_johnson@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIRationale and design of the oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets trial for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial)2009https://doi.org/10.1186/1471-2369-10-20
N.B. These documents automatically identified may not have been verified by the study sponsor.