Cranoc Lipid Study in Renal Transplantation

This study has been terminated.

(No possibilty to receive all plened patients for this study)

Sponsor:

Information provided by:

University of Schleswig-Holstein

ClinicalTrials.gov Identifier:

NCT00223041

First received: September 14, 2005

Last updated: August 4, 2011

Last verified: May 2006

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

August 4, 2011

Start Date ^ICMJE

April 2003

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary) [ Time Frame: during the study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)

Change History

Complete list of historical versions of study NCT00223041 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

patients and kidney survival [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
amount and typ of rejection (Banff-classifikation) [ Time Frame: during the study ] [ Designated as safety issue: No ]
change in lipids [ Time Frame: during the study ] [ Designated as safety issue: No ]
adverse events of the statin fluvastatin [ Time Frame: during the study ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

patients and kidney survival
amount and typ of rejection (Banff-classifikation)
change in lipids
adverse events of the statin fluvastatin

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Cranoc Lipid Study in Renal Transplantation

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Renal Transplantation

Intervention ^ICMJE

Drug: Fluvastatin

Arm A receives fluvastatin Arm b receives no fluvastatin

Study Arm (s)

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

Intervention: Drug: Fluvastatin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

200

Completion Date

December 2010

Primary Completion Date

November 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00223041

Other Study ID Numbers ^ICMJE

001

Has Data Monitoring Committee

Yes

Responsible Party

L. Renders, University of Kiel, department of Nephrology

Study Sponsor ^ICMJE

University of Schleswig-Holstein

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lutz Renders, MD

University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology

Information Provided By

University of Schleswig-Holstein

Verification Date

May 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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