Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000235606
Ethics application status
Approved
Date submitted
25/08/2005
Date registered
26/08/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determinants of vascualr dysfunction in chronic kidney disease
Scientific title
Determinants of vascualr dysfunction in chronic kidney disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease in chronic kidney disease 321 0
Condition category
Condition code
Cardiovascular 366 366 0 0
Other cardiovascular diseases
Renal and Urogenital 367 367 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
None
Intervention code [1] 268 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 427 0
Post-ischaemic flow-mediated dilatation of the brachial artery.
Timepoint [1] 427 0
Primary outcome [2] 428 0
Systemic arterial compliance (a measure of arterial elasticity).
Timepoint [2] 428 0
Secondary outcome [1] 920 0
1. Post-glyceryl trinitrate brachial artery vasodilatation
Timepoint [1] 920 0
Secondary outcome [2] 921 0
2. Lipid and lipoprotein concentration
Timepoint [2] 921 0
Secondary outcome [3] 922 0
3. Apolipoprotein B, CIII and AI concentration
Timepoint [3] 922 0
Secondary outcome [4] 923 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] 923 0

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
Sex
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
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
105
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 425 0
Commercial sector/Industry
Name [1] 425 0
Pfizer CVL grants
Country [1] 425 0
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country
United States of America
Secondary sponsor category [1] 344 0
None
Name [1] 344 0
None
Address [1] 344 0
Country [1] 344 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35213 0
Address 35213 0
Country 35213 0
Phone 35213 0
Fax 35213 0
Email 35213 0
Contact person for public queries
Name 9457 0
Dr. Sharan Dogra
Address 9457 0
Royal Perth Hospital
Level 3
MRF Building
GPO BOX X2213
Perth WA 6847
Country 9457 0
Australia
Phone 9457 0
+61 8 92240232
Fax 9457 0
Email 9457 0
[email protected]
Contact person for scientific queries
Name 385 0
Dr. Sharan Dogra
Address 385 0
Royal Perth Hospital
Level 3 MRF Building
GPO BOX X2213
Perth WA 6847
Country 385 0
Australia
Phone 385 0
+61 8 92240232
Fax 385 0
Email 385 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.