Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000726651
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
11/11/2005
Date last updated
12/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Kinetic Defects in Lipoprotein Metabolism in Patients with Renal Failure
Scientific title
Kinetic Defects in Lipoprotein Metabolism in Patients with Renal Failure
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic renal disease 877 0
Lipoprotein metabolism 878 0
Condition category
Condition code
Renal and Urogenital 946 946 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Nil.
Intervention code [1] 627 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 1243 0
1. ApoB and apoAI metabolism
Timepoint [1] 1243 0
Following recruitment
Primary outcome [2] 1244 0
2. Insulin sensitivity.
Timepoint [2] 1244 0
Following recruitment
Secondary outcome [1] 2264 0
Nil
Timepoint [1] 2264 0

Eligibility
Key inclusion criteria
Non-diabetic CRF (GFR 40-60 ml/min) and 20 age, sex and weight matched healthy controls.
Minimum age
20 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 or 2 Diabetes mellitus; Nephrotic Syndrome; Renal Replacement Therapy; BMI > 35 kg/m2; On lipid-modifying therapy; Alcohol consumption > 3 standard drinks / day; Liver disease; Primary dyslipidaemia (familial hypercholesterolaemia or familial combined hyperlipidaemia) or non-uraemia related secondary dyslipidaemia; Untreated thyroid disease; Significant psychiatric disorder; Cyclical hormone therapy in females.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1043 0
Commercial sector/Industry
Name [1] 1043 0
Cardiovascular Lipid Research Grant Pfizer
Country [1] 1043 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cardiovascular Lipid Research Grant Pfizer
Address
Country
United States of America
Secondary sponsor category [1] 905 0
University
Name [1] 905 0
University of Western Australia School of Medicine and Pharmacology
Address [1] 905 0
Rear 50 Murray Street
Perth WA 6000
Country [1] 905 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2345 0
Royal Perth Hospital
Ethics committee address [1] 2345 0
Ethics committee country [1] 2345 0
Australia
Date submitted for ethics approval [1] 2345 0
Approval date [1] 2345 0
Ethics approval number [1] 2345 0

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

Contacts
Principal investigator
Name 35528 0
Address 35528 0
Country 35528 0
Phone 35528 0
Fax 35528 0
Email 35528 0
Contact person for public queries
Name 9816 0
Dr Doris Chan
Address 9816 0
Department of Nephrology
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 9816 0
Australia
Phone 9816 0
+61 8 92242244
Fax 9816 0
Email 9816 0
doris.chan@health.wa.gov.au
Contact person for scientific queries
Name 744 0
Dr Sharan Dogra
Address 744 0
University of Western Australia
Medical Research Foundation Building
Level 3
Rear 50 Murray St
Perth WA 6000
Country 744 0
Australia
Phone 744 0
+61 8 92240232
Fax 744 0
Email 744 0
sdogra@meddent.uwa.edu.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
No additional documents have been identified.