Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients (4EVERLUNG)

Novartis

Status and phase

Completed

Phase 3

Conditions

Lung Transplantation

Treatments

Drug: standard therapy

Drug: Everolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01404325

CRAD001ADE36

2011-001539-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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