Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

• Status: Completed
• Trial end date: 2017-08-08
• Target enrollment: 0
• Participant gender: All

Summary

This trial evaluated the efficacy and safety of Everolimus in combination with tacrolimus versus a standard immunosuppressive regimen concerning kidney function in liver transplant recipients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Collaborator: Winicker Norimed GmbH
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion criteria:

Male or female recipients of a full-size liver allograft, aged 18 to 65 years.

Exclusion criteria:

Patients with thrombocytopenia (platelets <50,000/mm³), with an absolute neutrophil count of <1,000/mm³ or leucopenia (leucocytes <2000/mm³), with anemia with Hb < 6g/dl at time of randomization

Patients with uncontrolled hypercholesterolemia (>350mg/dL; >9mmol/L) or hypertriglyceridemia (>750 mg/dL; >8.5 mmol/L) at time of randomization

History of malignancy of any organ system within the past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC