Clinical trial NCT01551212: Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: Liver transplantation
Everolimus
Tacrolimus
Renal function
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Estimated Glomerular Filtration Rate (GFR)
timeFrame: month 12
Secondary outcomes:
measure: Estimated GFR - PP Set
timeFrame: month 12
measure: Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death
timeFrame: 12 months
measure: Number of Participants With HCV
timeFrame: 12 months
measure: Incidence of HCV Related Fibrosis
timeFrame: 12 months
measure: Incidence of de Novo HCC Malignancies
timeFrame: 12 months
measure: Incidence and Severity of CMV Viral Infections.
timeFrame: 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Tübingen
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Nashan B, Schemmer P, Braun F, Schlitt HJ, Pascher A, Klein CG, Neumann UP, Kroeger I, Wimmer P; Hephaistos Study Group. Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS Trial. Liver Transpl. 2022 Jun;28(6):998-1010. doi: 10.1002/lt.26298. Epub 2021 Oct 12.
citation: Nashan B, Schemmer P, Braun F, Dworak M, Wimmer P, Schlitt H. Evaluating the efficacy, safety and evolution of renal function with early initiation of everolimus-facilitated tacrolimus reduction in de novo liver transplant recipients: Study protocol for a randomized controlled trial. Trials. 2015 Mar 26;16:118. doi: 10.1186/s13063-015-0626-0.