Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000141640
Ethics application status
Approved
Date submitted
11/08/2005
Date registered
12/08/2005
Date last updated
19/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
CeMyLungs
Scientific title
A 3 year randomised, open label, multi-centre Investigator driven study comparing de Novo enteric coated Mycophenolate Sodium with delayed onset Everolimus, both arms in combination with Cyclosporin (using C2 monitoring) and Corticosteroids for the prevention of Bronchiolitis Obliterans Syndrome in Heart-Lung, Bilateral Lung and Single Lung Transplant recipients.
Secondary ID [1] 259935 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Lung, Bilateral Lung and Single Lung Transplant recipients 231 0
Condition category
Condition code
Surgery 262 262 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following bronchoscopic confirmation of bronchial anastomotic healing, the patients will be randomised to either continue Mycophenolate Sodium 1080mg BD, in combination with Cyclosporin and corticosteroids or switched to receive Everolimus (initial dose 1.5mg Bd), then dose adjusted on trough levels in combination with Cyclosporin and Corticosteroids. This treatment will continue for 3 years post transplantation.
Intervention code [1] 167 0
Treatment: Drugs
Comparator / control treatment
All patients are given Mycophenolate Sodium at time of transplant. At randomisation, they either continue with Mycophenolate Sodium or are switched onto Everolimus.
Control group
Active

Outcomes
Primary outcome [1] 307 0
To assess the incidence of patients with BOS, defined as a sustained fall (for > 1 month) in maximum FEV1 of 20% or more (compared to baseline) over 3 years post transplant.
Timepoint [1] 307 0
Over three years post transplant
Secondary outcome [1] 685 0
1. Assess the proportion of patients with each BOS grade
Timepoint [1] 685 0
At 1 and 3 years.
Secondary outcome [2] 686 0
2. Assess the proportion of patients with greater than or equal to 1 episode of acute allograft rejection.
Timepoint [2] 686 0
In the first year of treatment.
Secondary outcome [3] 687 0
3. The number of acute rejection episodes per patient per year and per hundred patient days.
Timepoint [3] 687 0
Per year (at year one, two and three) post transplant and per hundred patient days post transplant
Secondary outcome [4] 688 0
4. The time to first rejection.
Timepoint [4] 688 0
Over three years post transplant
Secondary outcome [5] 689 0
5. A composite vascular rejection score (sum of A grades divided by the postoperative days).
Timepoint [5] 689 0
At three years post transplant
Secondary outcome [6] 690 0
6. Sum of broncial rejection score (sum of B grades divided by the post operative days).
Timepoint [6] 690 0
At three years post transplant
Secondary outcome [7] 691 0
7. Patient and graft survival
Timepoint [7] 691 0
At 1 and 3 years.
Secondary outcome [8] 692 0
8. Treatmetn Failure: a) drug discontinuation, b) graft loss, c) patient death.
Timepoint [8] 692 0
Over three years post transplant
Secondary outcome [9] 693 0
9. SAE's & AE's as defined.
Timepoint [9] 693 0
Over three years post transplant

Eligibility
Key inclusion criteria
1. Recipients of a first heart-lung, bilateral lung or single lung allograft who are suitable to receive everolimus or mycophenolate sodium plus cyclosporin and corticosteroid triple therapy. 2. Patients capable of understanding the purposes and risks of the study and who have given informed written consent. 3. Male and female patients of childbearing age agree to maintain effective birth control practice during the study and fro 3 months after cessation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patietns who require immunosuppressive therapy other than study medication.2. Patients receiving a lobar lung transplant from a living donor.3. Patients who have received a prior ling or other organ transplant.4. Pregnant women and nursing mothers.5. Women unwilling to use adequate contraception during and for 3 months following the conclusion of treatment with study drug.6. Patients or their donors with serologic evidence of HIV, HbsAg or HCV antibodies.7. Patients with maligancies or history of malignancy with a recurrence free interval of < 5 years except non metastatic basal or squameous cell carcinoma of the skin that has bee treated successfully.8. 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 C or above on 2 occasions, or 39 degrees C accompanied by a culture of body fluid regarded as significant by the local laboratory and requiring antibiotic therapy.9. Patients with panresistant infections with Burkholderia cepacia or mycobacteria in the last year.10. Patients with renal insufficiency (creatinine clearance < 50ml/min)11. Patients with severe uncontrolled hypercholesterolaemia (greater than or equal too 350mg/dL, 9.1 mmol/L) or hypertriglyceridaemia (greater than or equal too 750mg/dL, 8.5 mmol/L).12. Patients with a white blood cell count of <2,500/mm3 or platlet count < 50,000/mm3.13. Presence of any severe allergy requiring acute or chronic treatment, or hypersensitivity to drugs similar to RAD (eg. erythromycin or other macrolide antibiotics) or to Myfortic.14. Patients on invasive ventilator devices or extracorporeal membrane oxygenators (ECMO).

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)
IVRS
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
PATIENTS WILL BE STRATIFIED AS TO WHETHER THEY HAVE CYSTIC FIBROSIS OR NOT, AND THEN RANDOMISED VIA IVRS
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 317 0
Commercial sector/Industry
Name [1] 317 0
Novartis
Country [1] 317 0
Switzerland
Primary sponsor type
Individual
Name
Professor Allan R. Glanville
Address
Heart Lung Transplant Unit St. Vincent's Hospital Xavier 4 Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 247 0
None
Name [1] 247 0
None
Address [1] 247 0
Country [1] 247 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1205 0
St. Vincent's Hospital
Ethics committee address [1] 1205 0
Sydney NSW
Ethics committee country [1] 1205 0
Australia
Date submitted for ethics approval [1] 1205 0
Approval date [1] 1205 0
Ethics approval number [1] 1205 0
Ethics committee name [2] 1206 0
Prince Charles Hospital
Ethics committee address [2] 1206 0
Brisbane QLD
Ethics committee country [2] 1206 0
Australia
Date submitted for ethics approval [2] 1206 0
Approval date [2] 1206 0
Ethics approval number [2] 1206 0

Summary
Brief summary
To assess the efficacy and safety of delayed onset Certican (Everolimus) compared to Myfortic (enteric coated Mycophenolate Sodium: MPS), both arms in combination with Cyclosporin A (CsA)(monitored by C2 levels) and corticosteroids for the prevention of chronic rejection (Bronchiolitis Obliterans Syndrome: BOS) in the first 3 years post transplant when given as de novo maintenance therapy for the management of lung allograft recipients after bronchial anastomotic healing has been confirmed at bronchoscopy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36388 0
Prof Allan R. Glanville
Address 36388 0
Heart Lung Transplant Unit St. Vincent's Hospital Xavier 4 Darlinghurst NSW 2010
Country 36388 0
Australia
Phone 36388 0
+61 2 8382 2175
Fax 36388 0
+61 2 9332 4267
Email 36388 0
[email protected]
Contact person for public queries
Name 9356 0
Prof Allan R. Glanville
Address 9356 0
Heart Lung Transplant Unit
St. Vincent's Hospital
Xavier 4
Darlinghurst NSW 2010
Country 9356 0
Australia
Phone 9356 0
+61 2 8382 2175
Fax 9356 0
+61 2 9332 4267
Email 9356 0
[email protected]
Contact person for scientific queries
Name 284 0
Mr Lee Mead
Address 284 0
Heart Lung Transplant Unit
St. Vincent's Hospital
Xavier 4
Darlinghurst NSW 2010
Country 284 0
Australia
Phone 284 0
+61 2 8382 4257
Fax 284 0
+61 2 9332 4267
Email 284 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

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