NCT00223054

Brief Summary

In this study the researchers want to investigate genetic polymorphisms of cytochrome 450 enzymes and the multiple drug resistance (MDR) gene in renal transplant patients to look for differences in dosing of immunosuppressive drugs (tacrolimus, sirolimus, everolimus, cyclosporine A). All patients who receive one of these drugs can be included and drug blood trough levels, dosing and genetics are compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

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

March 1, 2005

Completed
7 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
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

August 4, 2011

Status Verified

June 1, 2008

Enrollment Period

1.3 years

First QC Date

September 14, 2005

Last Update Submit

August 3, 2011

Conditions

Function of Renal Transplant

Keywords

cyclosporin ATacrolimusEverolimusSirolimusFluvastatin

Interventions

tacrolimusDRUG

retrospective analyze of drug levels in comparison to polymorphism

sirolimusDRUG

retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

everolimusDRUG

retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

cyclosporin ADRUG

retrospective of drug blood trough levels in comparison to polymorphism of enzymes of drug metabolism

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patinets after kidney transplantation

You may qualify if:

  • Renal transplant patients receiving one or more of the following drugs:
  • tacrolimus
  • sirolimus
  • everolimus
  • cyclosporin A
  • fluvastatin
  • Informed consent given by the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Kiel, 24105, Germany

Location

Related Publications (1)

  • Renders L, Frisman M, Ufer M, Mosyagin I, Haenisch S, Ott U, Caliebe A, Dechant M, Braun F, Kunzendorf U, Cascorbi I. CYP3A5 genotype markedly influences the pharmacokinetics of tacrolimus and sirolimus in kidney transplant recipients. Clin Pharmacol Ther. 2007 Feb;81(2):228-34. doi: 10.1038/sj.clpt.6100039. Epub 2006 Dec 27.

    PMID: 17192769RESULT

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples to analyze polymorphisms

MeSH Terms

Interventions

TacrolimusSirolimusEverolimusCyclosporine

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Lutz Renders, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

June 1, 2006

Study Completion

October 1, 2006

Last Updated

August 4, 2011

Record last verified: 2008-06

Locations

DE(1)