Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA Following Liver Transplantation

• Status: Unknown status
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

This study will enroll 60 subjects. 30 subjects in each of the two groups. Subjects will be followed for 1 year after liver transplant.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

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 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, ATG, or IVIG 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