Cranoc Lipid Study in Renal Transplantation

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00223041
• Other study ID #: 001
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: September 14, 2005
• Last updated: August 4, 2011
• Start date: April 2003
• Est. completion date: December 2010

Study information

• Verified date: May 2006
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Fluvastatin
Arm A receives fluvastatin Arm b receives no fluvastatin

Locations

Country	Name	City	State
Germany	University of Schleswig-Holstein, Campus Kiel, Department of Nephrology	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)		during the study	No
Secondary	patients and kidney survival		during the study	Yes
Secondary	amount and typ of rejection (Banff-classifikation)		during the study	No
Secondary	change in lipids		during the study	No
Secondary	adverse events of the statin fluvastatin		during the study	Yes