Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

Novartis Pharmaceuticals339 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

339

Conditions

Liver Transplantation

Interventions

EverolimusDRUG

tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg

TacrolimusDRUG

capsule containing 0.5, 1.0, or 5.0mg

CorticosteroidsDRUG

For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (15)

Novartis Investigative Site

Aachen, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bonn, Germany

Outcomes

Primary Outcomes

Estimated Glomerular Filtration Rate (GFR)

The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).

Time frame: month 12

Secondary Outcomes

Estimated GFR - PP Set

This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.

Time frame: month 12

Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death

Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12

Time frame: 12 months

Number of Participants With HCV

Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest

Time frame: 12 months

Incidence of HCV Related Fibrosis

Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest

Time frame: 12 months

Incidence of de Novo HCC Malignancies

Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest

Time frame: 12 months

Incidence and Severity of CMV Viral Infections.

Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.

Time frame: 12 months

Data from ClinicalTrials.gov

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