Phase 4
Completed N=59
Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation
Source: ClinicalTrials.gov NCT02123108 ↗Enrolled (actual)
59
Serious AEs
8.5%
Results posted
Sep 2022
Primary outcomePrimary: Renal Recovery/ Function — 28; 26 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This is an investigator initiated study at the University of California, Los Angeles (UCLA) funded by Novartis looking at using a combination of immunosuppressive drugs in liver transplant patients that are at risk of developing kidney problems. Kidney problems following liver transplants is the most problematic issue facing liver transplant patients today.
This study will generate information in this area of high unmet medical need utilizing basiliximab and Myfortic and using a reduced dose of tacrolimus, one of the current standard of care medications, after kidney function has normalized.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Renal Recovery/ Function |
28; 26 | — |
Eligibility Criteria
Inclusion Criteria
Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- >18 years old
- Undergoing first or second OLT
- MELD (model for end-stage liver disease) score >25
- Serum creatinine > 1.5 or ongoing hemodialysis for less than 4 weeks at the time of transplant
- Able and agreeable to conform to requirements of the study
- Patients or proxy must give written informed consent before any assessment is performed.
Exclusion Criteria
- <18 years old
- Serum creatinine <1.5
- MELD Score < 25
- Ongoing hemodialysis for 4 or more weeks (those patients become eligible for renal transplants at that point per UCLA practice).
- Receiving OKT3 (Muromonab-CD3), ATG (Antithymocyte Globulin), or IVIG (Intravenous Immunoglobulin Therapy) therapy around time of transplant
- Participating in another clinical research study involving the evaluation of another investigational drug or device
- Prior documented allergy to any of the study medications
- Active Fungal infection
Data sourced from ClinicalTrials.gov (NCT02123108). 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.