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Trial registered on ANZCTR


Trial ID
ACTRN12605000240640
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
31/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of statin and fibrate therapy on vascular function in chronic kidney disease
Scientific title
The effect of statin and fibrate therapy on vascular function in chronic kidney disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascualr disease in patients with chronic kidney disease 326 0
Condition category
Condition code
Cardiovascular 374 374 0 0
Other cardiovascular diseases
Renal and Urogenital 375 375 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Atorvastatin 40mg, Gemfibrozil 600mg BD for 6 weeks.
Intervention code [1] 266 0
Treatment: drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 433 0
Post-ischaemic flow-mediated dilatation of the brachial artery.
Timepoint [1] 433 0
Measured at baseline (week 0) and at the end of week 6.
Primary outcome [2] 434 0
Systemic arterial compliance (a measure of arterial elasticity).
Timepoint [2] 434 0
Measured at baseline (week 0) and at the end of week 6.
Secondary outcome [1] 947 0
1. Post-glyceryl trinitrate brachial artery vasodilatation.
Timepoint [1] 947 0
Measured at baseline (week 0) and at end of week 6.
Secondary outcome [2] 948 0
2. Lipid and lipoprotein concentration.
Timepoint [2] 948 0
Measured at baseline (week 0) and at end of week 6.
Secondary outcome [3] 949 0
3. Apolipoprotein B, CIII and AI concentration.
Timepoint [3] 949 0
Measured at baseline (week 0) and at end of week 6.
Secondary outcome [4] 950 0
4. Markers of inflammation (CRP, IL-6), oxidative stress (plasma isoprostanes and dityrosine), nitric oxide bioavailability (cyclic guanosine monophosphate - cGMP), and thrombosis (fibrinogen, plasminogen activator inhibitor - PAI-1, e-selectin and vascular cell adhesion molecule - VCAM-1).
Timepoint [4] 950 0
Measured at baseline (week 0) and at end of week 6.

Eligibility
Key inclusion criteria
All patients on haemodialysis or peritoneal dialysis for Chronic kidney disease, including patients with diabetes; Patients should be stable on dialysis for at least 6 months with adequate indices of dialysis (Fractional Reduction of Urea, FRU > 0.67 or Kt/V > 0.3); All patients with moderate-to-severe chronic kidney disease (GFR < 40ml/min), including patients with diabetes.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nephrotic-range proteinuria; Active upper gastro-intestinal dyspepsia; Muscular disorders; Liver and muscle enzymes > 2 times upper limit of normal; Alcohol consumption > 3 standard drinks/day; Use of antioxidant vitamin supplements other than multivitamin B/folic acid preparations routinely used in haemodialysis patients; Immunosuppressive therapy for renal transplantation; Cardiovascular event or unstable cardiovascular disease in preceding 6 months; Drugs known to affect lipid-metabolism (eg. fish oil supplements); Significant psychiatric disorder; Active infection.

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 was performed centrally using random number tables by the Pharmacy department (distant department not involved with the trial directly) this ensuring the allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software Microsoft XP Excel to generate random number tables. Randomisation stratified for treatment mode block 1: (predialysis, haemodialysis or peritoneal dialysis) and block 2: (diabetes mellitus or no diabetes mellitus).
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
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 431 0
Commercial sector/Industry
Name [1] 431 0
Pfizer CVL grants
Address [1] 431 0
Country [1] 431 0
Primary sponsor type
Commercial sector/Industry
Name
Pfizer CVL Grants
Address
Country
Australia
Secondary sponsor category [1] 349 0
Commercial sector/Industry
Name [1] 349 0
Pfizer
Address [1] 349 0
Country [1] 349 0
United States of America

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35105 0
Address 35105 0
Country 35105 0
Phone 35105 0
Fax 35105 0
Email 35105 0
Contact person for public queries
Name 9455 0
Dr. Sharan Dogra
Address 9455 0
Royal Perth Hospital
Level 3 MRF Building
GPO BOX X2213
Perth WA 6847
Country 9455 0
Australia
Phone 9455 0
+61 8 92240232
Fax 9455 0
Email 9455 0
sdogra@cyllene.uwa.edu.au
Contact person for scientific queries
Name 383 0
Dr. Sharan Dogra
Address 383 0
Royal Perth Hospital
Level 3 MRF Building
GPO BOX X2213
Perth WA 6847
Country 383 0
Australia
Phone 383 0
+61 8 92240232
Fax 383 0
Email 383 0
sdogra@cyllene.uwa.edu.au