Overview
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
Status:
Completed
Completed
Trial end date:
2017-01-05
2017-01-05
Target enrollment:
0
0
Participant gender:
All
All
Summary
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsCollaborator:
Crolll GmbhTreatments:
Everolimus
Immunosuppressive Agents
Sirolimus
Criteria
Inclusion criteria:- Adult recipients of de novo cadaveric lung transplants 3-18 months prior to enrollment
Exclusion criteria:
- Patients with thrombocytopenia (platelets <100,000/mm³), with an absolute neutrophil
count of <1,500/mm³ or leucopenia (leucocytes <3000/mm³), with anemia with Hb < 8g/dl
at time of screening
- Patients with uncontrolled hypercholesterolemia (> 350 mg/dL; > 9.1 mmol/L) or
hypertriglyceridemia (> 750 mg/dL; > 8.5 mmol/L) at time of screening
- Patients with a history of malignancy of any organ system, treated or untreated,
during the last five years, whether or not there is evidence of local recurrence or
metastases, except squamous or basal cell carcinoma of the skin Other protocol-defined
inclusion/exclusion criteria may apply