NCT00223015

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2004

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

October 20, 2005

Status Verified

May 1, 2004

First QC Date

September 14, 2005

Last Update Submit

October 19, 2005

Conditions

Renal Transplantation

Keywords

renal transplantationpharmacokineticsFluvastatinMycophenolat mofetiltacrolimus

Interventions

Fluvastatin, Tacrolimus, Mycophenolat MofetilDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • contraindications for statins
  • pregnancy or lactating
  • elevated liver or muscle encymes (\> 2x up to normal values: AST, ALT, bilirubine, CPK)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

FluvastatinTacrolimus

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Lutz Renders, MD

    University of Schleswig-Holstein, campus Kiel Department odf Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

May 1, 2004

Study Completion

April 1, 2005

Last Updated

October 20, 2005

Record last verified: 2004-05