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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00223028

Enrollment

Registered

2005-09-22

Start date

2005-04-30

Completion date

2005-07-31

Last updated

2005-10-28

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

Conditions

Renal Transplantation

Keywords

fluvastain, sirolimus, mycophenolat mofetil, renal transplantation

Brief 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

Interventions

DRUGsirolimus, mycophenolat mofetil, fluvastatin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

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: 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)

Outcome results

None listed

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