Official Title: “A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, 6-Month Study to Establish the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vascular Graft Disease in de Novo Renal Transplant Patients”

Principal objective is to investigate if the treatment with fluvastatin can prevent the progression of vascular graft disease in de novo renal transplant patients.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Intervention(s) in this Clinical Trial

• Drug: Fluvastatin
  • Graft vasculopathy

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • fluvastatin 40mg b.i.d.
• Placebo Comparator: 2
  • Placebo b.i.d.

Primary Measures

• To determine if treatment with fluvastatin can prevent the progression of vascular graft disease. The difference between the vascular intimal thickness measured on the baseline biopsy and the biopsy at the end of the study between the two treatment group
  • Time Frame: three Yrs
    Safety Issue?: Yes

Secondary Measures

• 24-hour creatinine and proteinuria values at 6 months post-transplant, graft survival and patient survival at 6 months, differences in lipid profile between the treatment groups, incidence of rejection episodes treated and documented by biopsy at 6
  • Time Frame: Three yrs
    Safety Issue?: Yes

Inclusion criteria:

• Patients where the investigator expects to prescribe cyclosporine, mycophenolate mofetil and corticosteroids as base immunosuppressive therapy, regardless of their participation in the study.
• Man or woman aged from 17 to 70 years.
• Patients that receive a first or second renal transplant from a non-living donor
• Patients where allograft biopsies may be performed.
• Patients receiving an identical or compatible ABO graft.
• Patients willing to give their written informed consent to all study issues.
• Women with child-bearing potential should use a medically proven contraceptive method during the study.
• Patients able to meet all study requirements.

Exclusion criteria:

• Patients with pre-transplant cholesterol levels above 240 mg/dl (6.2 mmol/l).
• Positive cross-match of T cells or ABO incompatibility with the donor.
• Recipients of multiorgan transplant.
• Patients with diabetes mellitus.
• HIV seropositive or with surface antigen of Hepatitis B .
• Kidney from a donor aged over 65 years.
• Last panel of reactive antibody (PRA) above 50%.
• Women who plan to get pregnant within 12 months, or who are pregnant and/or nursing.
• Patients with a history of cancer in the previous 5 years, except for patients successfully treated with localized carcinoma of squamous or basal cells of the skin, or cervix cancer in situ treated adequately.
• Patients receiving an investigational drug in the 30 days prior to the transplant and/or who will receive an investigational/non-registered drug during the study, except for the use of erythropoietin-stimulating products
• Patients with myocardial infarction within the 6 months prior to the transplant, uncontrollable cardiac arrhythmia or another severe or unstable medical condition probably affecting the safety of the patient or the study objectives.
• Patients with alcohol dependence or drug abuse not solved, or signs of organic lesion caused by alcohol, mental dysfunction or other factors limiting their ability to fully cooperate with the study.
• Patients where it is planned to perform an induction treatment with preparations containing antilymphocyte antibodies (ALG, ATG or OKT-3).
• Patients scheduled to receive cyclosporine i.v. for over 48 hours.
• Patients with liver dysfunction (ALT or AST values or total bilirubin 2 times above the upper limit of the normal ranges of the laboratory values).
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Study Director Novartis  

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565474

Study ID Number: LESTX-ES-01

ClinicalTrials.gov Identifier: NCT00565474

Health Authority: Spain: Comité Ético de Investigación Clínica