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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2005-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Renal Transplantation

Keywords

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fluvastain sirolimus mycophenolat mofetil renal transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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sirolimus, mycophenolat mofetil, fluvastatin

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Lutz Renders, MD

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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003

Identifier Type: -

Identifier Source: org_study_id