NCT00565474

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2007

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6.1 years

First QC Date

November 28, 2007

Last Update Submit

February 21, 2017

Conditions

Graft Vasculopathy

Keywords

Renal transplantationfluvastatin

Outcome Measures

Primary Outcomes (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

    three Yrs

Secondary Outcomes (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

    Three yrs

Study Arms (2)

1

ACTIVE COMPARATOR

fluvastatin 40mg b.i.d.

Drug: Fluvastatin

2

PLACEBO COMPARATOR

Placebo b.i.d.

Drug: Fluvastatin

Interventions

FluvastatinDRUG

Graft vasculopathy

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Barcelona, Spain

Location

Related Publications (1)

  • Seron D, Oppenheimer F, Pallardo 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.

    PMID: 18622282RESULT

MeSH Terms

Interventions

Fluvastatin

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2007

First Posted

November 30, 2007

Study Start

September 1, 2001

Primary Completion

October 1, 2007

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

ES(1)