Trial registered on ANZCTR


Trial ID
ACTRN12605000599673
Ethics application status
Approved
Date submitted
12/08/2005
Date registered
5/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
RAD in the Treatment of Pulmonary Fibrosis
Scientific title
An investigator driven, randomised, placebo controlled, double blind, multi-centre study to assess the safety and efficacy of RAD (Everolimus) in the treatment of pulmonary fibrosis
Universal Trial Number (UTN)
Trial acronym
CRAD001AAU01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 728 0
Condition category
Condition code
Respiratory 805 805 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
RAD 4mg po Bd
Intervention code [1] 179 0
Treatment: drugs
Comparator / control treatment
Placebo 4 tablets po Bd.
Control group
Placebo

Outcomes
Primary outcome [1] 1033 0
To assess the efficacy and safety of RAD in the treatment of pulmonary
fibrosis. Efficacy is defined by stabilisation or improvement in baseline parameters of lung function; six-minute walk test distance (6MWT), resting arterial oxygen tension (PaO2), Quality of Life (QOL) score and Borg dyspnoea scale.
Timepoint [1] 1033 0
At intervals of 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months from randomisation.
Secondary outcome [1] 1922 0
To assess the incidence and timing of the fall in lung function parameters.
Timepoint [1] 1922 0
From baseline.
Secondary outcome [2] 1923 0
To assess the incidence and timing of the development of respiratory failure and to assess survival.
Timepoint [2] 1923 0
At 6 months, 1 and 3 years.

Eligibility
Key inclusion criteria
A diagnosis of pulmonary fibrosis who are eligible to receive RAD. Patients capable of understanding the purposes and risks of the study and who give informed written consent.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Patients receiving immunosuppression other than study medication. NB patients receiving a mean dose of 10mg Prednisolone / day or steroid equivalent and who have been on a stable dose for at least 4 weeks will be allowed entry into the trial. ii. Pregnant women, nursing mothers.iv.Female/Male patients unwilling to maintain adequate birth-control during and for 3 months following the conclusion of study.iv. Patients with active malignancies or a history of malignancy with a recurrence free interval of 5 years (except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully).v. Patients with serological evidence of HIV, HbsAg or HCV antibodies.vi. Patients with respiratory failure requiring invasive ventilation.vii.Patients with systemic infections requiring therapy at the time of entry into the study. A systemic infection is defined as a body temperature of 38 degrees or above on 2 occasions, or 39 degrees accompanied by a positive culture of body fluid regarded as significant by the local laboratory which requires antibiotic therapy.viii. Patients with a concomitant major illness such as (a) cardiac or (b) renalinsufficiency (creatinine clearance 0ml/min).ix. Patients with severe uncontrolled hypercholesterolemia (9.1 mmol/L) (350mg/dL) or hypertriglyceridemia (5.6 mmol/L) (500mg/dL).x. Patients with a history of significant coagulopathy or a medical condition requiring long term systemic anticoagulation. Low dose aspirin will be allowed.

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 will be performed by Novartis Drug Supply Management using a validated system that automates the random assignment of treatment groups to randomisation numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be assigned the next available randomisation number at the centre, in sequence, within the patient's randomisation stratum.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Patients will be stratified according to diagnostic groups as follows: Stratum 1 UIP, Stratum 2 CTD
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Safety/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] 892 0
Commercial sector/Industry
Name [1] 892 0
novartis
Address [1] 892 0
Country [1] 892 0
Primary sponsor type
Individual
Name
Dr Monique Malouf
Address
Country
Secondary sponsor category [1] 754 0
None
Name [1] 754 0
None
Address [1] 754 0
Country [1] 754 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2175 0
The Alfred Hospital
Ethics committee address [1] 2175 0
Ethics committee country [1] 2175 0
Australia
Date submitted for ethics approval [1] 2175 0
Approval date [1] 2175 0
Ethics approval number [1] 2175 0
Ethics committee name [2] 2176 0
The Prince Charles Hospital
Ethics committee address [2] 2176 0
Ethics committee country [2] 2176 0
Australia
Date submitted for ethics approval [2] 2176 0
Approval date [2] 2176 0
Ethics approval number [2] 2176 0
Ethics committee name [3] 2177 0
Queen Elizabeth Hospital
Ethics committee address [3] 2177 0
Ethics committee country [3] 2177 0
Australia
Date submitted for ethics approval [3] 2177 0
Approval date [3] 2177 0
Ethics approval number [3] 2177 0
Ethics committee name [4] 2178 0
Sir Charles Gairdner Hospital
Ethics committee address [4] 2178 0
Ethics committee country [4] 2178 0
Australia
Date submitted for ethics approval [4] 2178 0
Approval date [4] 2178 0
Ethics approval number [4] 2178 0
Ethics committee name [5] 2179 0
Royal Perth Hospital
Ethics committee address [5] 2179 0
Ethics committee country [5] 2179 0
Australia
Date submitted for ethics approval [5] 2179 0
Approval date [5] 2179 0
Ethics approval number [5] 2179 0

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

Contacts
Principal investigator
Name 35556 0
Address 35556 0
Country 35556 0
Phone 35556 0
Fax 35556 0
Email 35556 0
Contact person for public queries
Name 9368 0
Dr Monique Malouf
Address 9368 0
St. Vincent's Hospital
Xavier 4
Victoria Street
Darlinghurst NSW 2010
Country 9368 0
Australia
Phone 9368 0
+61 2 83822175
Fax 9368 0
+61 2 83823084
Email 9368 0
mmalouf@stvincents.com.au
Contact person for scientific queries
Name 296 0
Lisa Singleton
Address 296 0
St. Vincent's Hospital
Xavier 4
Victoria Street
Darlinghurst NSW 2010
Country 296 0
Australia
Phone 296 0
+61 2 83822175
Fax 296 0
+61 2 83823084
Email 296 0
mmalouf@stvincents.com.au