Phase 4
N=339
Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01551212 ↗Enrolled (actual)
339
Serious AEs
63.7%
Results posted
May 2019
Primary outcome: Primary: Estimated Glomerular Filtration Rate (GFR) — 73.46; 71.95 mL/min — p=0.097
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Everolimus (Drug); Tacrolimus (Drug); Corticosteroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2017
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 | — |
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 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). 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.