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Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients
Phase 4 trial testing Everolimus in Liver Transplantation in 339 participants. Completed in 8 August 2017.
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 339 |
| Start date | 24 May 2012 |
| Primary completion | 8 August 2017 |
| Estimated completion | 8 August 2017 |
| Sites | 15 locations across Germany |
Novartis Pharmaceuticals — full company profile →
Adults 18 to 65, any sex, with Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The estmated GFR was calculated using MDRD-4 formula (Modification of Diet in Renal Disease Study Group).
| Group | Value | 95% CI |
|---|---|---|
| Everolimus/Tacrolimus | 73.46 | ± 25.57 |
| Tacrolimus | 71.95 | ± 27.17 |
This was a sensitivity analysis for the primary outcome measure based on the per-protocol set of patients.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus/Tacrolimus | 74.83 | ± 25.19 |
| Tacrolimus | 70.65 | ± 24.91 |
Percentage of Participants with Treated Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death at Month 12
| Group | Value | 95% CI |
|---|---|---|
| Everolimus/Tacrolimus | 9.5 | |
| Tacrolimus | 7.9 |
Number of Participants with HCV (hepatitis C virus) assessed as treatment emergent adverse events of special interest
| Group | Value | 95% CI |
|---|---|---|
| Everolimus/Tacrolimus | 6 | |
| Tacrolimus | 12 |
Incidence of hepatitis C virus (HCV) related fibrosis assessed as treatment emergent adverse events of special interest
| Group | Value | 95% CI |
|---|---|---|
| Everolimus/Tacrolimus | 1 | |
| Tacrolimus | 0 |
Incidence of de novo Hepatocellular Carcinoma (HCC) malignancies assessed as treatment emergent adverse events of special interest
| Group | Value | 95% CI |
|---|---|---|
| Everolimus/Tacrolimus | 0 | |
| Tacrolimus | 2 |
Incidence and severity of cytomegalovirus (CMV) viral infections assessed as treatment emergent adverse events of special interest.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus/Tacrolimus | 136 | |
| Tacrolimus | 129 | |
| Everolimus/Tacrolimus | 0 | |
| Tacrolimus | 5 | |
| Everolimus/Tacrolimus | 16 | |
| Tacrolimus | 20 | |
| Everolimus/Tacrolimus | 13 | |
| Tacrolimus | 9 |
Time frame: Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit up to approximately 12 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Everolimus/Tacrolimus | Tacrolimus |
|---|---|---|---|
| CHOLANGITIS | Hepatobiliary disorders | — | — |
| BILIARY ANASTOMOSIS COMPLICATION | Injury, poisoning and procedural complications | — | — |
| LIVER TRANSPLANT REJECTION | Immune system disorders | — | — |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | — | — |
| PNEUMONIA | Infections and infestations | — | — |
| ACUTE KIDNEY INJURY | Renal and urinary disorders | — | — |
| HEPATIC ENZYME INCREASED | Investigations | — | — |
| BILE DUCT STENOSIS | Hepatobiliary disorders | — | — |
| CHOLANGITIS INFECTIVE | Infections and infestations | — | — |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | — | — |
| TRANSAMINASES INCREASED | Investigations | — | — |
| ASCITES | Gastrointestinal disorders | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — |
| BILIARY ISCHAEMIA | Hepatobiliary disorders | — | — |
| HEPATITIS C | Infections and infestations | — | — |
| LIVER ABSCESS | Infections and infestations | — | — |
| URINARY TRACT INFECTION | Infections and infestations | — | — |
| C-REACTIVE PROTEIN INCREASED | Investigations | — | — |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — |
| VOMITING | Gastrointestinal disorders | — | — |
| PYREXIA | General disorders | — | — |
| CHOLESTASIS | Hepatobiliary disorders | — | — |
| INFECTION | Infections and infestations | — | — |
| SEPSIS | Infections and infestations | — | — |
| Reaction | System | Everolimus/Tacrolimus | Tacrolimus |
|---|---|---|---|
| HEADACHE | Nervous system disorders | — | — |
| LEUKOPENIA | Blood and lymphatic system disorders | — | — |
| DIARRHOEA | Gastrointestinal disorders | — | — |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | — | — |
| OEDEMA PERIPHERAL | General disorders | — | — |
| INCISIONAL HERNIA | Injury, poisoning and procedural complications | — | — |
| URINARY TRACT INFECTION | Infections and infestations | — | — |
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | — | — |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | — | — |
| HYPERTENSION | Vascular disorders | — | — |
| PROTEINURIA | Renal and urinary disorders | — | — |
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | — | — |
| TREMOR | Nervous system disorders | — | — |
| IMPAIRED HEALING | General disorders | — | — |
| ABDOMINAL PAIN | Gastrointestinal disorders | — | — |
| ANAEMIA | Blood and lymphatic system disorders | — | — |
| NAUSEA | Gastrointestinal disorders | — | — |
| BLOOD CREATININE INCREASED | Investigations | — | — |
| ASCITES | Gastrointestinal disorders | — | — |
| PYREXIA | General disorders | — | — |
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | — | — |
| C-REACTIVE PROTEIN INCREASED | Investigations | — | — |
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders | — | — |
| HYPERKALAEMIA | Metabolism and nutrition disorders | — | — |
| BACK PAIN | Musculoskeletal and connective tissue disorders | — | — |
| VOMITING | Gastrointestinal disorders | — | — |
| PRURITUS | Skin and subcutaneous tissue disorders | — | — |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | — | — |
| HYPERLIPIDAEMIA | Metabolism and nutrition disorders | — | — |
| RENAL FAILURE | Renal and urinary disorders | — | — |
| RENAL IMPAIRMENT | Renal and urinary disorders | — | — |
| COUGH | Respiratory, thoracic and mediastinal disorders | — | — |
| CONSTIPATION | Gastrointestinal disorders | — | — |
| HEPATIC ENZYME INCREASED | Investigations | — | — |
| HEPATIC STEATOSIS | Hepatobiliary disorders | — | — |
| GAMMA-GLUTAMYLTRANSFERASE INCREASED | Investigations | — | — |
| APHTHOUS ULCER | Gastrointestinal disorders | — | — |
| DIABETES MELLITUS | Metabolism and nutrition disorders | — | — |
| HYPOKALAEMIA | Metabolism and nutrition disorders | — | — |
| IRON DEFICIENCY | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: CHOLANGITIS, BILIARY ANASTOMOSIS COMPLICATION, LIVER TRANSPLANT REJECTION, INCISIONAL HERNIA, PNEUMONIA, ACUTE KIDNEY INJURY, HEPATIC ENZYME INCREASED, BILE DUCT STENOSIS.
Data from ClinicalTrials.gov NCT01551212 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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