Investigation of the Steady State Pharmacokinetics of Tacrolimus, Mycophenolate Mofetil and Fluvastatin After Renal Transplantation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223015

Enrollment

Registered

2005-09-22

Start date

2004-05-31

Completion date

2005-04-30

Last updated

2005-10-20

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, pharmacokinetics, Fluvastatin, Mycophenolat mofetil, tacrolimus

Brief summary

Steady state pharmacokinetics of tacrolimus, mycophenolat mofetil and fluvastatin in renal transplant patients are investigated to look for potential interaction between these drugs. 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 were included

Interventions

DRUGFluvastatin, Tacrolimus, Mycophenolat Mofetil

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* renal transplant patients (18 - 65 years, inclusive) * cadaver and living renal transplants(1. Ntx, 2. Ntx) * Immunsuppression: Tacrolimus 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)

Outcome results

None listed

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