Phase 3
N=203
Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy
Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00378014 ↗Enrolled (actual)
203
Serious AEs
63.0%
Results posted
Jul 2014
Primary outcome: Primary: Calculated Glomerular Filtration Rate (cGFR) — 87.9; 84.1 mL/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- everolimus (Drug); basiliximab (Drug); CNI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calculated Glomerular Filtration Rate (cGFR) |
87.9; 84.1 | — |
| SECONDARY Incidence of Efficacy Failure |
20.8; 20.4 | — |
| SECONDARY Incidence of the Need for a Change in the Immunosuppressive Regimen |
80.2; 73.5 | — |
| SECONDARY Incidence of Renal Deterioration |
— | — |
| SECONDARY Renal Function (cGFR) |
88.7; 82.9 | — |
| SECONDARY Incidence of Treated BPAR |
13.5; 10.2 | — |
| SECONDARY Patient and Graft Survival |
4.3; 4.1; 2.2; 2.1 | — |
| SECONDARY Hepatitis C Virus (HCV) Replication in HCV-positive Patients |
64.5; 55.3; 0.0; 0.0; 35.5; 44.7 | — |
| SECONDARY Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death |
41; 40; 26; 28; 1; 2 | — |
| SECONDARY Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death |
41; 40; 26; 28; 1; 2 | — |
Summary
The study is designed to show that everolimus initiation together with reduction and thereafter discontinuation of calcineurin inhibitor (CNI) will improve significantly renal function in de novo liver transplant recipients as compared to continuation of CNI-based treatment.
Eligibility Criteria
Inclusion Criteria
- Males or females 18 - 70 years old
- Liver transplant recipient (living or deceased donor)
- Patients in whom an allograft biopsy will not be contraindicated
Exclusion Criteria
- Recipients of multiple solid organ transplants or patients that have already received a transplant in the past
- HCV positive patients who need an active anti-viral treatment (HCV- positive patients without active antiviral treatment are allowed)
- HIV positive patients
- Patients who are breast feeding
- Patients with a current severe systemic infection
- Presence of any hypersensitivity to drugs similar to Certican® (e.g. macrolides)
- Preexisting (i.e. not related to CNI-damage) renal dysfunction that, according to the judgment of the investigator, will not significantly improve after transplantation (i.e., for example, patients that are expected to have a cGFR below 50ml/min at 4 weeks post transplantation)
- Patients that have received Simulect prior to this study.
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00378014). 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.