Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients (HEPHAISTOS)

Novartis

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation

Treatments: Drug: Tacrolimus; Drug: Everolimus; Drug: Corticosteroids

Study type: Interventional

Funder types: Industry

Identifiers

NCT01551212

2011-003118-17 (EudraCT Number)

CRAD001HDE13

Details and patient eligibility

About

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.

Enrollment: 339 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

339 participants in 2 patient groups

EVR/TAC

Experimental group

Description:

Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)

Treatment:

Drug: Corticosteroids

Drug: Everolimus

Drug: Tacrolimus

TAC

Active Comparator group

Description:

Tacrolimus (C0-h: 6-10 ng/ml)

Treatment:

Drug: Corticosteroids

Drug: Tacrolimus