Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

Liver Transplantation Clinical Trial

— HEPHAISTOS  

Official title:

A 12-month, Multi-center, Open-label, Randomized, Controlled Study to Evaluate Efficacy/Safety and Evolution of Renal Function of Everolimus in Co-exposure With Tacrolimus in de Novo Liver Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551212
• Other study ID #: CRAD001HDE13
• Secondary ID: 2011-003118-17
• Status: Completed
• Phase: Phase 4
• Start date: May 24, 2012
• Est. completion date: August 8, 2017

Study information

• Verified date: May 2019
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: August 8, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Everolimus
tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg
• Tacrolimus
capsule containing 0.5, 1.0, or 5.0mg
• Corticosteroids
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.

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Aachen
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mainz
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated Glomerular Filtration Rate (GFR)	The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).	month 12
Secondary	Estimated GFR - PP Set	This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.	month 12
Secondary	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	12 months
Secondary	Number of Participants With HCV	Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest	12 months
Secondary	Incidence of HCV Related Fibrosis	Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest	12 months
Secondary	Incidence of de Novo HCC Malignancies	Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest	12 months
Secondary	Incidence and Severity of CMV Viral Infections.	Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.	12 months