Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000690651
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
25/10/2005
Date last updated
18/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Rosiglitazone on Vascular Function in Patients with Advanced Chronic Kidney Disease
Scientific title
The Effect of Rosiglitazone on Vascular Function in Patients with Advanced Chronic Kidney Disease
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Chronic kidney disease 838 0
Vascular function 839 0
Condition category
Condition code
Renal and Urogenital 906 906 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, double blind, placebo-controlled, parallel-group study of rosiglitazone 4mg/day vs placebo for 8 weeks
Intervention code [1] 625 0
None
Comparator / control treatment
matching placebo given orally for 8 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 1178 0
1. Post-ischaemic flow-mediated dilatation of the brachial artery.
Timepoint [1] 1178 0
After 8 weeks of treatment
Primary outcome [2] 1179 0
2. Systemic arterial compliance (a measure of arterial elasticity)
Timepoint [2] 1179 0
After 8 weeks of treatment
Primary outcome [3] 1180 0
3. Augmentation Index (a measure of arterial stiffness)
Timepoint [3] 1180 0
After 8 weeks of treatment
Secondary outcome [1] 2153 0
1. Pulse wave velocity and pulse wave velocity index
Timepoint [1] 2153 0
After 8 weeks of treatment
Secondary outcome [2] 2154 0
2. Insulin sensitivity as measured by a euglycaemic clamp and the HOMA score
Timepoint [2] 2154 0
After 8 weeks of treatment
Secondary outcome [3] 2155 0
3. Cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, apolipoprotein B, and AI concentration
Timepoint [3] 2155 0
After 8 weeks of treatment
Secondary outcome [4] 2156 0
4. Markers of inflammation (CRP, IL-6) and thrombosis (fibrinogen, plasminogen activator inhibitor - PAI-1).
Timepoint [4] 2156 0
After 8 weeks of treatment
Secondary outcome [5] 2157 0
5. 24-hour ambulatory blood pressure
Timepoint [5] 2157 0
After 8 weeks of treatment

Eligibility
Key inclusion criteria
All patients on haemodialysis or peritoneal dialysis for Chronic kidney disease, 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 stages 3-5 chronic kidney disease (GFR < 60ml/min); Patients will be selected for having the Metabolic Syndrome as defined by the WHO criteria [31] based on our previous data showing that these patients had markedly impaired vascular function:1. Insulin resistance identified by 1 of the following: Type 2 diabetes, impaired fasting glucose > 6.1 mmol/L, impaired glucose tolerance or increased fasting insulin > 75th percentile for the population (8 mU/L).PLUS ANY 2 OF THE FOLLOWING:1. Antihypertensive medication and/or systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90 mmHg.2. Plasma triglycerides > 1.7 mmol/L3. HDL-cholesterol < 0.9 mmol/L in men and < 1.0 mmol/L in women4. Body mass index > 30 kg/m2 and/or waist:hip ratio > 0.9 in men and 0.85 in women5. Urinary albumin excretion rate >= 20 microg/min.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Type 1 diabetes mellitus; Nephrotic-range proteinuria; Liver enzymes > 2 times upper limit of normal; Alcohol consumption > 3 standard drinks/day; Immunosuppressive therapy for renal transplantation; Cardiovascular event or unstable cardiovascular disease in preceding 6 months; Symptomatic or NYHA heart failure stage III or IV; Hb < 110g/L; Significant psychiatric disorder; Active infection or inflammation.

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)
Allocation by a distant unit (pharmacy)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random sequence with Block randomisation substratified for dialysis mode or predialysis, and for presence or absence of diabetes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 999 0
Charities/Societies/Foundations
Name [1] 999 0
Raine Medical Research foundation
Country [1] 999 0
Australia
Funding source category [2] 4365 0
Commercial sector/Industry
Name [2] 4365 0
GlaxoSmithKline Australia
Country [2] 4365 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Raine Medical Research foundation (pending)
Address
Raine Medical Research Foundation
Suite 24, Hollywood Specialist Centre
95 Monash Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 860 0
University
Name [1] 860 0
University of Western Australia School of Medicine and Pharmacology
Address [1] 860 0
Rear 50 Murray Streeet
Perth WA 6000
Country [1] 860 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35953 0
Address 35953 0
Country 35953 0
Phone 35953 0
Fax 35953 0
Email 35953 0
Contact person for public queries
Name 9814 0
Dr Doris Chan
Address 9814 0
Department of Nephrology
Royal Perth Hospital
Wellington Street Campus
Perth WA 6000
Country 9814 0
Australia
Phone 9814 0
+61 8 92242244
Fax 9814 0
Email 9814 0
[email protected]
Contact person for scientific queries
Name 742 0
Dr Sharan Dogra
Address 742 0
University of Western Australia
Medical Research Foundation Building
Level 3
Rear 50 Murray Street
Perth WA 6000
Country 742 0
Australia
Phone 742 0
+61 8 92240232
Fax 742 0
Email 742 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
SourceTitleYear of PublicationDOI
Dimensions AIRosiglitazone does not improve vascular function in subjects with chronic kidney disease2011https://doi.org/10.1093/ndt/gfr049
N.B. These documents automatically identified may not have been verified by the study sponsor.