Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000693628
Ethics application status
Approved
Date submitted
11/10/2005
Date registered
28/10/2005
Date last updated
28/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
LORD TRIAL
Scientific title
A randomised placebo controlled phase IV study to assess the effects of atorvastatin on the rate of decline of glomerular filtration rate in chronic kidney disease patients
Universal Trial Number (UTN)
Trial acronym
LORD Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 842 0
Condition category
Condition code
Renal and Urogenital 909 909 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a three year study to determine the effect of an HMG-CoA reductase inhibitor on the progression of renal disease
Intervention code [1] 709 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1183 0
The primary outcome is decline in estimated glomerular filtration rate, assessed using the Cockroft and Gault forumula
Timepoint [1] 1183 0
Every three months from baseline until completion of the study or need for renal replacement therapy.
Secondary outcome [1] 2161 0
The secondary outcomes are
- Rate of serum creatinine increase
- Rate of reciprocal of serum creatinine increase
- Rate of creatinine clearance decrease
- Rate of proteinuria increase
- Rate of albuminuria increase
Timepoint [1] 2161 0
These rate measures will be determined from blood/urine samples every 3 months from baseline until completion of the study or need for renal replacement therapy.
Secondary outcome [2] 2162 0
Time to halving of GFR
Time to doubling of serum creatinine
Timepoint [2] 2162 0
Also determined from the 3 monthly blood/urine samples.
Secondary outcome [3] 2163 0
The need for renal replacement therapy
The nutritional status, quality of life and functional status
Timepoint [3] 2163 0
Determined from questionnaires completed every 9 months from baseline until completion of the study or need for renal replacement therapy.
Secondary outcome [4] 2164 0
The number of hospital admissions and
Cardiovascular events.
Mortality, and causes of death
Determined from patient records
Timepoint [4] 2164 0
Secondary outcome [5] 2165 0
The safety of long-term administration of atorvastatin® to normalise lipid levels.
Timepoint [5] 2165 0
Determined from blood/urine samples every 3 months from baseline until completion of the study or need for renal replacement therapy.

Eligibility
Key inclusion criteria
Chronic Kidney Disease, Serum Creatinine >130 umol for males and >120 umol for females.GFR< 60ml/min.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already taking a statinA seizure within a year of study entryHypersensitivity to atorvastatinParticipation or proposed participation in another clinical investigational study drug within 30 days.

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 performed by pharmacy department at the LGH and it was randomised permuted block, stratified according to cause of renal disease. Concealment is randomisation allocation in sequentially labelled opaque heat sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation performed by computer program at the pharmacy department, LGH, Launceston
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1002 0
Charities/Societies/Foundations
Name [1] 1002 0
Clifford Craig Medical Research Trust
Country [1] 1002 0
Australia
Funding source category [2] 1003 0
Commercial sector/Industry
Name [2] 1003 0
Pfizer Pharmaceutical
Country [2] 1003 0
Primary sponsor type
Hospital
Name
Launceston General Hospital
Address
Country
Australia
Secondary sponsor category [1] 863 0
None
Name [1] 863 0
NA
Address [1] 863 0
Country [1] 863 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35911 0
Address 35911 0
Country 35911 0
Phone 35911 0
Fax 35911 0
Email 35911 0
Contact person for public queries
Name 9898 0
Lisa Anderson and Marianne Smith
Address 9898 0
Renal Research Tasmania
Clifford Craig Medical Research Trust
Launceston General Hospital (LGH)
Level 5
Charles Street
Launceston TAS 7250
Country 9898 0
Australia
Phone 9898 0
+61 3 63487026
Fax 9898 0
+61 3 63487090
Email 9898 0
lisa.anderson@dhhs.tas.gov.au and marianne.smith@dhhs.tas.gov.au
Contact person for scientific queries
Name 826 0
Associate Professor Rob Fassett and Dr Jeff Coombes
Address 826 0
Renal Research Tasmania
Clifford Craig Medical Research Trust
Launceston General Hospital (LGH)
Level 5
Charles Street
Launceston TAS 7250
Country 826 0
Australia
Phone 826 0
Rob: +61 3 63487190 and Jeff: +61 7 33656767
Fax 826 0
Rob: +61 3 63487577 and Jeff: +61 7 33656877
Email 826 0
rob.fassett@dhhs.tas.gov.au and jcoombes@hms.uq.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.