A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate whether tacrolimus dose reduction in de novo renal recipients receiving everolimus can preserve renal function while maintaining efficacy.

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

Details

• Lead Sponsor: Novartis
• Treatments: Antibodies, Monoclonal; Basiliximab; Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion criteria

• Male or female of 18-65 years old

• Patient who has received a primary kidney transplant from a cadaveric, living unrelated or non-human leucocyte antigen (HLA) identical living related donor

• Recipient of a kidney with a cold ischemia time (CIT) < 30 hours

• Recipient of a kidney from a donor 10-65 years old

• Patient able to receive the first dose of tacrolimus within 24 hours from graft reperfusion

• Female capable of becoming pregnant must have a negative pregnancy test and is required to practice a medically approved method of birth control for the duration of the study and for a period of three months following discontinuation of investigational drug

• Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion criteria

• Patient who has previously received an organ transplant

• Recipient of multiple organ transplants

• Recipient of a kidney transplant from a non heart-beating donor

• Recipient of donor specific transfusions

• Recipient of A-B-O incompatible transplant or T-cell cross-match positive transplant

• Patient with current Panel Reactive Antibodies (PRA) level ≥ 50%

• Recipient of a kidney from a donor who tests positive for hepatitis B surface antigen or hepatitis C antibodies

• Patient who is human immunodeficiency virus (HIV) positive

• Patient who has a positive hepatitis C serology or who is hepatitis B surface antigen positive with evidence of liver injury as indicated by aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels ≥2.5 times upper limit of normal (UNL). Viral serology results obtained within 6 months prior to the administration of the first dose of Certican™ are acceptable

• Patient with severe hypercholesterolemia (350 mg/dL, 9.1 mmoL/dL) or hypertriglyceridemia ( 500 mg/dL, 5.6 mmoL/L)

• Patient with white blood cell (WBC) count 3,000/mm3 or with platelet count 75,000/mm3

• Patient with any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or with hypersensitivity to drugs similar to Certican (e.g., macrolides)

• Patient who has been treated with an immunosuppressive drug or an investigational drug within 4 weeks prior to the administration of the first dose of Certican

• Patient with uncontrolled infection

• Patient with any surgical or medical condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment in this trial

• Patient with a known malignancy or a history of malignancy within last 5 years other than successfully treated localized basal or squamous cell carcinoma of the skin

• Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to the administration of the first dose of Certican™ which at investigator's discretion would interfere with the objectives of the study

• Breast feeding women

• Patient with symptoms of significant somatic or mental illness or with unresolved history of drug or alcohol abuse

• Patient unable to cooperate or communicate with the investigator