Cranoc Lipid Study in Renal Transplantation

NCT00223041 | Terminated Phase 2 DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplantation

Keywords

renal transplantation; cardiovasculary disease; statin

Outcome Measures

Primary Outcomes (1)

• cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)

  during the study

Secondary Outcomes (4)

• 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

Study Arms (2)

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

Fluvastatin DRUG

Arm A receives fluvastatin Arm b receives no fluvastatin

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

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

Kiel, 24251, Germany

Location

MeSH Terms

Interventions

Fluvastatin

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Lutz Renders, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2003
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2010
• Last Updated: August 8, 2011

Record last verified: 2006-05

Locations

DE (1)