Phase 4
Completed N=339
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
Source: ClinicalTrials.gov NCT01551212 ↗Enrolled (actual)
339
Serious AEs
63.7%
Results posted
May 2019
Primary outcomePrimary: Estimated Glomerular Filtration Rate (GFR) — 73.46; 71.95 mL/min — p=0.097
◆ Published Evidence
Established
30citations · ~8 / year
Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS 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.
Linked Publications (2)
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Early Everolimus-Facilitated Reduced Tacrolimus in Liver Transplantation: Results From the Randomized HEPHAISTOS Trial.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Glomerular Filtration Rate (GFR) |
73.46; 71.95 | 0.097 |
| SECONDARY Estimated GFR - PP Set |
74.83; 70.65 | 0.0085 sig |
| SECONDARY Percentage of Participants With Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death |
9.5; 7.9 | 0.699 |
| SECONDARY Number of Participants With HCV |
6; 12 | — |
| SECONDARY Incidence of HCV Related Fibrosis |
1; 0 | — |
| SECONDARY Incidence of de Novo HCC Malignancies |
0; 2 | — |
| SECONDARY Incidence and Severity of CMV Viral Infections. |
136; 129; 0; 5; 16; 20 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01551212) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.