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 - Full Text View

Purpose

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

Condition	Intervention	Phase
Graft Vasculopathy	Drug: Fluvastatin	Phase 4


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

Resource links provided by NLM:

MedlinePlus related topics: Kidney Transplantation Vascular Diseases

Drug Information available for: Fluvastatin Fluvastatin sodium

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome 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 ] [ Designated as safety issue: Yes ]


Enrollment:	84
Study Start Date:	September 2001
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 fluvastatin 40mg b.i.d.	Drug: Fluvastatin Graft vasculopathy
Placebo Comparator: 2 Placebo b.i.d.	Drug: Fluvastatin Graft vasculopathy

Eligibility


Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565474

Locations


Spain
Novartis Investigative Site
Barcelona, Spain

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators


Study Director:	Novartis	Novartis

More Information


Responsible Party:	Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00565474 History of Changes
Other Study ID Numbers:	LESTX-ES-01
Study First Received:	November 28, 2007
Last Updated:	April 20, 2016
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Novartis:


Renal transplantation fluvastatin

Additional relevant MeSH terms:


Vascular Diseases Cardiovascular Diseases Fluvastatin Anticholesteremic Agents Hypolipidemic Agents	Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 26, 2016