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

Novartis

Status and phase: Withdrawn; Phase 3

Conditions: Liver Transplantation

Treatments: Drug: TAC withdrawal; Drug: Everolimus with reduced TAC

Study type: Interventional

Funder types: Industry

Identifiers

NCT03596970

CRAD001HDE53

Details and patient eligibility

About

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)

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Everolimus with MMF (TAC-withdrawal)

Experimental group

Description:

Everolimus (RAD001) with MMF and Steroids

Treatment:

Drug: TAC withdrawal

Everolimus with reduced TAC

Active Comparator group

Description:

Everolimus (RAD001) with reduced TAC and Steroids

Treatment:

Drug: Everolimus with reduced TAC