Phase 4
N=171
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
Liver Transplant
Bottom Line
View on ClinicalTrials.gov: NCT00149994 ↗Enrolled (actual)
171
Serious AEs
43.9%
Results posted
Feb 2011
Primary outcome: Primary: Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation. — 33.3; 32.9 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Cyclosporine A (Drug); Tacrolimus (Drug); Basiliximab (Drug); Methylprednisolone (Drug); Prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Occurrence of Biopsy Proven Acute Rejection (BPAR) During the First 3 Months Post de Novo Liver Transplantation. |
33.3; 32.9 | — |
Summary
The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.
Eligibility Criteria
Inclusion Criteria
- About to undergo a primary liver transplant (including living donor, non-heart beating donor and split liver).
- Age between 18 and 75 years.
- Expected to be able to receive the first oral dose of CNI within the first 24 hours post-transplantation (Tx)
Exclusion Criteria
- This is a multi-organ transplant or if the patient has previously been transplanted with any other organ.
- Urine production is <200 ml within 12 hours after reperfusion of the graft
- Severe coexisting disease is present or if any unstable medical condition is present which could affect the study objectives.
Other protocol-defined exclusion criteria applied
Data sourced from ClinicalTrials.gov (NCT00149994). 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.