Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

Phase 4

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: Everolimus; Drug: Corticosteroids; Drug: Tacrolimus

• Registration Number: NCT01551212
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-12
• Study Start: 2012-05-24
• Primary Completion: 2017-08-08
• Study Completion: 2017-08-08
• Results First Submitted: 2018-08-02
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-09
• Last Update Submitted: 2019-05-09
• Results First Posted: 2019-05-10
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAC	Corticosteroids	Tacrolimus (C0-h: 6-10 ng/ml)
EVR/TAC	Corticosteroids	Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)
EVR/TAC	Tacrolimus	Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)
EVR/TAC	Everolimus	Tacrolimus minimization arm. Everolimus (C0-h: 3-8 ng/mL) + tacrolimus (C0-h: \< 5 ng/mL)
TAC	Tacrolimus	Tacrolimus (C0-h: 6-10 ng/ml)

Primary Outcome Measures

Name	Time	Method
Estimated Glomerular Filtration Rate (GFR)	month 12	The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).

Secondary Outcome Measures

Name	Time	Method
Estimated GFR - PP Set	month 12	This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.
Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death	12 months	Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12
Number of Participants With HCV	12 months	Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest
Incidence of HCV Related Fibrosis	12 months	Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest
Incidence and Severity of CMV Viral Infections.	12 months	Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.
Incidence of de Novo HCC Malignancies	12 months	Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Tübingen, Germany