Clinical trial NCT00369161: 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
Official title: A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With IL-2 Receptor Antagonist, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

Primary outcomes:
measure: Renal Function Assessed by Calculated Glomerular Filtration Rate (cGFR)
timeFrame: 12 months post -transplant
Secondary outcomes:
measure: Number of Participants With Incidence of Biopsy-proven Acute Rejection (BPAR)
timeFrame: from Month 4 through to Month 12
measure: Percentage of Participants With Efficacy Failure
timeFrame: Month 12
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Langer RM, Hene R, Vitko S, Christiaans M, Tedesco-Silva H Jr, Ciechanowski K, Cassuto E, Rostaing L, Vilatoba M, Machein U, Ulbricht B, Junge G, Dong G, Pascual J. Everolimus plus early tacrolimus minimization: a phase III, randomized, open-label, multicentre trial in renal transplantation. Transpl Int. 2012 May;25(5):592-602. doi: 10.1111/j.1432-2277.2012.01465.x. Epub 2012 Mar 26.