CeMyLungs

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000141640

Enrollment

320

Registered

2005-08-12

Start date

2005-08-03

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

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.

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).

Outcome results