Cranoc Lipid Study in Renal Transplantation

University Hospital Schleswig-Holstein (UKSH)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Renal Transplantation

Treatments: Drug: Fluvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00223041

001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups, including a placebo group

A (therapy with fluvastatin 80mg retard)

No Intervention group

Description:

kidney transplants receive in addition fluvastatin 80mg retard for 3 years

B

Placebo Comparator group

Description:

no therapy with fluvastatin

Treatment:

Drug: Fluvastatin