Cranoc Lipid Study in Renal Transplantation | NCT00223041

Studies
Cranoc Lipid Study in Renal Transplantation

NCT00223041

Sponsor

University Hospital Schleswig-Holstein

Status

Terminated

Last Update Posted

Aug 8, 2011Estimated

Enrollment

200Estimated

Phase

Phase 2Phase 3

Conditions

Renal Transplantation

Interventions

Fluvastatin

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No possibilty to receive all plened patients for this study

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 14, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2011

Last Update Posted Date

Aug 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A (therapy with fluvastatin 80mg retard)	No Intervention	kidney transplants receive in addition fluvastatin 80mg retard for 3 years
B	Placebo Comparator	no therapy with fluvastatin	Drug: Fluvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluvastatin	Drug	Arm A receives fluvastatin Arm b receives no fluvastatin	B

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
patients and kidney survival		during the study
amount and typ of rejection (Banff-classifikation)		during the study
change in lipids

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lutz Renders, MD	University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Schleswig-Holstein, Campus Kiel, Department of Nephrology		Kiel		24251	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D000077340	Fluvastatin

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

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