A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients

Completed · Phase 2

Conditions studied: Kidney Transplantation

In brief

A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen.

Key facts

Study ID

NCT00282568

Run by

Astellas Pharma Inc

People needed

70

Starts

2002-08-01

Expected to finish

2008-10-01

Last updated by the study team

2013-09-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is currently receiving Prograf ® based immunosuppressive therapy for kidney transplantation.
• Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable

You may not qualify if…

• Patient has previously received an organ transplant other than a kidney
• Patient is currently receiving sirolimus immunosuppression therapy.

Where it is running

• Study site — San Diego, California, United States
• Study site — Miami, Florida, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Madison, Wisconsin, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.