Cranoc Lipid Study in Renal Transplantation

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Detailed Description
-----------------
Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Official Title
-----------------
Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Fluvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients (18 - 65, inclusive) cadaver and living kidney transplantation (1. Ntx, 2. Ntx) LDL-cholesterol ≤ 130mg/dl (-3 Mo until start of Tx) Patients with a history of Myocard infarct: LDL-Cholesterol ≤ 110mg/dl Immunsuppression: Tacrolimus in combination with steroids or Mycophenolat Mofetil patients indulgence Exclusion Criteria: statin before the study LDL-Cholesterol >130mg/dl before transplantation Instabil Angina, Myocard infarct <6 months before transplantation symptomatic Hypothyreosis child bearing, lactating elavated liver encymes (> 2x elavated: AST, ALT, bilirubine, PCK) Fibrates are not allowed multiorgantransplantation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A (therapy with fluvastatin 80mg retard)<br>kidney transplants receive in addition fluvastatin 80mg retard for 3 years | |
| Placebo Comparator: B<br>no therapy with fluvastatin | Drug: Fluvastatin<br>* Arm A receives fluvastatin Arm b receives no fluvastatin<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary) |  | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patients and kidney survival |  | during the study | 
| amount and typ of rejection (Banff-classifikation) |  | during the study | 
| change in lipids |  | during the study | 
| adverse events of the statin fluvastatin |  | during the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal transplantation, cardiovasculary disease, statin