Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000447358
Ethics application status
Approved
Date submitted
20/08/2008
Date registered
8/09/2008
Date last updated
8/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pravastatin in Polycystic Kidney Disease
Scientific title
Effect of Pravastatin on Kidney Function in Polycystic Kidney Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Kidney Disease 3585 0
Condition category
Condition code
Renal and Urogenital 3745 3745 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pravastatin 20mg orally daily for 2 years
Intervention code [1] 3301 0
Treatment: Drugs
Comparator / control treatment
Control group with no treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4644 0
Serum Creatinine (blood analysis)
Timepoint [1] 4644 0
every 3 months for 2 years
Secondary outcome [1] 7852 0
Proteinuria measured by 24 hour urine collection
Timepoint [1] 7852 0
every 3 months for 2 years

Eligibility
Key inclusion criteria
Polycystic kidney disease
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Females of Child bearing potential

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)
Patients screened and identified as having polycystic kidney disease attending the nephrologists clinics offered enrollment
Independent central co-ordinator performs randomization from computer generated random numbers placed in concealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/1998
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3761 0
Charities/Societies/Foundations
Name [1] 3761 0
Clifford Craig Medical Research Trust
Country [1] 3761 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Research Trust
Address
Launceston General Hospital
Charles St, Launceston, 7250
Country
Australia
Secondary sponsor category [1] 3362 0
None
Name [1] 3362 0
Address [1] 3362 0
Country [1] 3362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5821 0
Epworth Research and Ethics Committee
Ethics committee address [1] 5821 0
Ethics committee country [1] 5821 0
Australia
Date submitted for ethics approval [1] 5821 0
Approval date [1] 5821 0
11/02/1997
Ethics approval number [1] 5821 0
9096S

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28854 0
Address 28854 0
Country 28854 0
Phone 28854 0
Fax 28854 0
Email 28854 0
Contact person for public queries
Name 12011 0
Professor Robert Fassett
Address 12011 0
Renal Research Tasmania
Launceston General Hospital
Charles Street
Launceston
Tasmania
Country 12011 0
Australia
Phone 12011 0
0419399571
Fax 12011 0
0363487577
Email 12011 0
[email protected]
Contact person for scientific queries
Name 2939 0
Professor Robert Fassett
Address 2939 0
Renal Research Tasmania
Launceston
Charles Street
Launceston Tasmania
Country 2939 0
Australia
Phone 2939 0
0419399571
Fax 2939 0
0363487577
Email 2939 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.