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TerminatedNCT00223041Updated Aug 8, 2011

Cranoc Lipid Study in Renal Transplantation

A Phase 2/3 interventional study of Fluvastatin in Renal Transplantation, sponsored by University Hospital Schleswig-Holstein. Terminated at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-08-08.

Sponsored by University Hospital Schleswig-Holstein · Phase 2/3, Interventional, and Prevention

Why this study was terminated
No possibilty to receive all plened patients for this study
Phase
Phase 2/3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Renal Transplantation

Keywords

  • renal transplantation
  • cardiovasculary disease
  • statin
03

In context

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • 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

Interventions

  • DrugFluvastatin

    Arm A receives fluvastatin Arm b receives no fluvastatin

06

What researchers measure

Primary outcomes

  1. cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)

    Time frame: during the study

Secondary outcomes

  1. patients and kidney survival

    Time frame: during the study

  2. amount and typ of rejection (Banff-classifikation)

    Time frame: during the study

  3. change in lipids

    Time frame: during the study

  4. adverse events of the statin fluvastatin

    Time frame: during the study

07

Study locations

1 site
  • University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
    Kiel, 24251, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00223041
Lead sponsor
University Hospital Schleswig-Holstein
First posted
Sep 22, 2005
Start date
Apr 2003
Primary completion
Nov 2009
Completion
Dec 2010
Last update
Aug 8, 2011

Study contacts

Lutz Renders, MD
principal investigator · University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2006. You cannot join it, but the record below documents what was studied.

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