Evaluation of the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vasculopathy of the Graft in de Novo Renal Transplant Patients Transplant

Condition(s) targeted: Graft Vasculopathy

Intervention: Fluvastatin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

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

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

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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

Secondary outcome: 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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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

Novartis Investigative Site, Barcelona, Spain

Starting date: September 2001
Ending date: October 2007
Last updated: November 29, 2007