Cranoc Lipid Study in Renal Transplantation

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223041

Enrollment

200

Registered

2005-09-22

Start date

2003-04-30

Completion date

2010-12-31

Last updated

2011-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

renal transplantation, cardiovasculary disease, statin

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

Interventions

DRUGFluvastatin

Arm A receives fluvastatin Arm b receives no fluvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026