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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

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ClinicalTrials.gov Identifier: NCT00565474
Recruitment Status : Completed
First Posted : November 30, 2007
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Graft Vasculopathy Drug: Fluvastatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2001
Actual Primary Completion Date : October 2007

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1
fluvastatin 40mg b.i.d.
 Drug: Fluvastatin
Graft vasculopathy
Placebo Comparator: 2
Placebo b.i.d.
 Drug: Fluvastatin
Graft vasculopathy


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565474


Locations
Spain
Novartis Investigative Site
Barcelona, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00565474     History of Changes
Other Study ID Numbers: LESTX-ES-01
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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