Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.

• Status: Withdrawn
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Everolimus; Sirolimus

Criteria

Inclusion Criteria:

• Patients willing and capable of providing written informed consent for study participation.

• Adults 18 to 70 years of age.

• Liver allograft from a deceased or living donor.

• Treated with a CNI containing immunosuppressive regimen.

• Liver transplant 6 to 24 months prior to screening.

• Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function.

• Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).

Exclusion Criteria:

• Multiple solid organ transplant recipients

• Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis

• Malignant diseases other than neoplasms of the skin.

• Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.

• Pregnant or nursing (lactating) women.

• Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).

• Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria

• HIV positivity

Other protocol-defined inclusion/exclusion criteria may apply.