Cranoc Lipid Study in Renal Transplantation

August 4, 2011 updated by: University Hospital Schleswig-Holstein

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, 24251
        • University of Schleswig-Holstein, Campus Kiel, Department of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Schleswig-Holstein

Investigators

  • Principal Investigator: Lutz Renders, MD, University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 8, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 001 (NavyGHB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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