Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Renal Transplantation Clinical Trial

Official title:

Investigation of the Steady State Pharmacokinetics of Sirolimus, Mycophenolat Mofetil and Fluvastatin After Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223028
• Other study ID #: 003
• Status: Completed
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: October 27, 2005
• Start date: April 2005
• Est. completion date: July 2005

Study information

• Verified date: July 2004
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To investigate in renal transplant recipients the potential drug intreaction between Sirolimus, Mycophenolt Mofetil and Fluvastatin

All patient enrolled in this PKI-Study had no changes in the therapy before or because of the study. Only patients without changes more than 4 weeks before startin the study were included

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• renal transplant patients (18 - 65 years, inclusive)

• cadaver and living renal transplants(1. Ntx, 2. Ntx)

• Immunsuppression: sirolimus with or without Mycophenolat Mofetil und and fluvastatin Fluvastatin for a minimum of three months

• writen informt consent by the patient

Exclusion Criteria:

• contraindications for statins

• pregnancy or lactating

• elevated liver or muscle encymes (> 2x up to normal values: AST, ALT, bilirubine, CPK)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• sirolimus, mycophenolat mofetil, fluvastatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein