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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00565474
First received: November 28, 2007
Last updated: February 21, 2017
Last verified: February 2017
November 28, 2007
February 21, 2017
September 2001
October 2007   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00565474 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (masked roles unspecified)
Primary Purpose: Prevention
Graft Vasculopathy
Drug: Fluvastatin
Graft vasculopathy
  • Active Comparator: 1
    fluvastatin 40mg b.i.d.
    Intervention: Drug: Fluvastatin
  • Placebo Comparator: 2
    Placebo b.i.d.
    Intervention: Drug: Fluvastatin
Serón D, Oppenheimer F, Pallardó LM, Lauzurica R, Errasti P, Gomez-Huertas E, Bosmans JL, Sanchez-Plumed J, Romero R, Marques M, Fulladosa X, Moreso F. Fluvastatin in the prevention of renal transplant vasculopathy: results of a prospective, randomized, double-blind, placebo-controlled trial. Transplantation. 2008 Jul 15;86(1):82-7. doi: 10.1097/TP.0b013e318174428d.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
Not Provided
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00565474
LESTX-ES-01
Not Provided
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP