Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000058572
Ethics application status
Approved
Date submitted
19/01/2006
Date registered
9/02/2006
Date last updated
14/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early Intervention in Acute Renal Failure
Scientific title
A multi-site randomised phase IV study to evaluate the effectiveness of intravenous erythropoietin in preventing intensive care unit patients with acute kidney injury from developing acute renal failure.
Universal Trial Number (UTN)
Trial acronym
EARLY ARF 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 1022 0
Condition category
Condition code
Renal and Urogenital 1099 1099 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intravenous Erythropoietin in 2 doses at 0 and 24 hours after the detection of a raised urinary acute kidney injury index
Intervention code [1] 848 0
Treatment: Drugs
Comparator / control treatment
placebo in 2 doses at 0 and 24 hours after the detection of a raised urinary acute kidney injury index
Control group
Placebo

Outcomes
Primary outcome [1] 1466 0
The achieved plasma creatinine levels
Timepoint [1] 1466 0
7 days after randomisation. Plasma creatinine will be monitored for up to 12 months after the intervention.
Secondary outcome [1] 2626 0
Dialysis free survival
Timepoint [1] 2626 0
Patients will be followed up for 12 months after enrollment.
Secondary outcome [2] 2627 0
Dialysis free interval
Timepoint [2] 2627 0
Patients will be followed up for 12 months after enrollment.
Secondary outcome [3] 2628 0
Duration of ICU stay
Timepoint [3] 2628 0
Patients will be followed up for 12 months after enrollment.
Secondary outcome [4] 2629 0
Mortality rate
Timepoint [4] 2629 0
Patients will be followed up for 12 months after enrollment.
Secondary outcome [5] 2630 0
eGFR (estimated Glomerular Filtration Rate)
Timepoint [5] 2630 0
Patients will be followed up for 12 months after enrollment.
Secondary outcome [6] 2631 0
Creatinine at 30 days.
Timepoint [6] 2631 0
Patients will be followed up for 12 months after enrollment.

Eligibility
Key inclusion criteria
1. Gamma Glutamyl Transpeptidase X Alkaline Phosphatase index of >46.3 u/mmol. 2. Likely survival >72 hours. 3. Consent obtained.
Minimum age
16 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active cytotoxic chemotherapy in progress2. Pre existing renal disease (serum creatinine >0.345 mmol/L)3. presence of rhabdomyolysis and/or myoglobinuria4. Already enrolled in another interventional study or previously enrolled in this study5. Increase of plasma creatinine of > 43 µmol/L over the previous 24 hours.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The pharmacy department will allocate blinded drug/placebo containing syringes according to a stratified randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator has been used and stratified for location. The generator of random number is in-house software developed specifically for randomisation in clinical trials wriiten in visual basic.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment outside Australia
Country [1] 261 0
New Zealand
State/province [1] 261 0

Funding & Sponsors
Funding source category [1] 1202 0
Government body
Name [1] 1202 0
The Health Research Council of New Zealand
Country [1] 1202 0
New Zealand
Primary sponsor type
Government body
Name
The Health Research Council of New Zealand
Address
PO Box 5541, Wellesley Street, Auckland, New Zealand
Country
New Zealand
Secondary sponsor category [1] 1061 0
None
Name [1] 1061 0
Nil
Address [1] 1061 0
Country [1] 1061 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2540 0
Multi-regional ethics-the Intensive Care Units in Christchurch Hospital
Ethics committee address [1] 2540 0
Ethics committee country [1] 2540 0
New Zealand
Date submitted for ethics approval [1] 2540 0
Approval date [1] 2540 0
Ethics approval number [1] 2540 0
Ethics committee name [2] 2541 0
Multi-regional ethics-the Intensive Care Units in Dunedin Hospital
Ethics committee address [2] 2541 0
Ethics committee country [2] 2541 0
New Zealand
Date submitted for ethics approval [2] 2541 0
Approval date [2] 2541 0
Ethics approval number [2] 2541 0

Summary
Brief summary
Patients admitted to a general intensive care unit and high risk post cardiothoracic surgery patients will be screened for renal injury using urinary biomarkers and randomised within 6 hours of admission to two doses of placebo or erythropoietin at 24 hour intervals. Subjects, investigators and treating clinicians will be blinded to
treatment throughout the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35249 0
Address 35249 0
Country 35249 0
Phone 35249 0
Fax 35249 0
Email 35249 0
Contact person for public queries
Name 10037 0
Dr John Pickering
Address 10037 0
Research Manager/Research Fellow
Christchurch Kidney Research Group Department of Medicine Christchurch School of Medicine and Health Sciences PO Box 4345 Christchurch
Country 10037 0
New Zealand
Phone 10037 0
+64 0 33641112
Fax 10037 0
+64 0 33640935
Email 10037 0
[email protected]
Contact person for scientific queries
Name 965 0
Professor Zoltan Endre
Address 965 0
Head of Department
Department of Medicine
Christchurch School of Medicine and Health Sciences
PO Box 4345
Christchurch
Country 965 0
New Zealand
Phone 965 0
+64 0 33641847
Fax 965 0
+64 0 33640935
Email 965 0
[email protected]

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
No additional documents have been identified.