This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Written informed consent obtained.
Subject randomized within 24 hr of completion of transplant surgery.
Recipient of a kidney with a cold ischemia time \< 30 hours.
Recipient of a primary (or secondary, if first graft is not lost due to immunological reasons) renal transplant from a deceased heart beating, living unrelated, living related non-human leukocyte antigen identical or an expanded criteria donor.

Criterios de exclusión

Subject unable to tolerate oral medication at time of randomization.
Use of other investigational drugs at the time of enrollment.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Multi-organ transplant recipient.
Recipient of ABO incompatible allograft or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant.
Subject at high immunological risk for rejection as determined by local practice for assessment of anti-donor reactivity e.g. high PRA, presence of pre-existing DSA.
Subject who is HIV-positive.
HBsAg and/or a HCV positive subject with evidence of elevated LFTs (ALT/AST levels ≥ 2.5 times ULN). Viral serology results obtained within 6 months prior to randomization are acceptable.
Recipient of a kidney from a donor who tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV).
Subject with a BMI greater than 35.
Subject with severe systemic infections, current or within the two weeks prior to randomization.
Subject requiring systemic anticoagulation.
History of malignancy of any organ system.
Subject with severe restrictive or obstructive pulmonary disorders.
Subject with severe hypercholesterolemia or hypertriglyceridemia that cannot be controlled.
Subject with white blood cell (WBC) count ≤ 2,000 /mm3 or with platelet count ≤ 50,000 /mm3.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.

Intervenciones

biological

Induction therapy

All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.

drug

Corticosteroids

All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.

drug

EVR+rCNI

Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)

drug

MPA+sCNI

Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).

Ubicaciones

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

San Martín, Buenos Aires, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Corrientes, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Santa Fe, Argentina

A 24 Month, Multicenter, Randomized, Open-label Safety and Efficacy Study of Concentration-controlled Everolimus With Reduced Calcineurin Inhibitor vs Mycophenolate With Standard Calcineurin Inhibitor in de Novo Renal Transplantation

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Induction therapy

Corticosteroids

EVR+rCNI

MPA+sCNI

Ubicaciones

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Novartis Investigative Site

Patrocinadores