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

Phase 4

Completed

• Conditions: Graft Vasculopathy
• Interventions: Drug: Fluvastatin

• Registration Number: NCT00565474
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2007-10
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-29
• Study First Posted: 2007-11-30
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Fluvastatin	fluvastatin 40mg b.i.d.
2	Fluvastatin	Placebo b.i.d.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇪🇸 Barcelona, Spain