Pharmacokinetic Comparison Of All FK-506 Formulations

Completed · Phase 3

Conditions studied: Renal Failure

In brief

The purpose of the study is to compare the pharmacokinetic parameters of three different formulations of tacrolimus. Eligible patients will be treated with all three formulations in a pre-defined sequence.

Key facts

Study ID

NCT02339246

Run by

Veloxis Pharmaceuticals

People needed

32

Starts

2015-01-01

Expected to finish

2015-03-01

Last updated by the study team

2016-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Renal transplant recipients, males or females, of 18 years of age or above.
• Able to participate and willing to give written informed consent and to comply with study visits and restrictions.
• Able to understand English.
• Patients having received a primary or secondary renal transplant

You may not qualify if…

• Evidence of acute rejection episode within the past three months prior to screening.
• Recipients of organ transplants other than kidney.
• Patients who are known to be HIV positive.

Where it is running

• University of Cincinnati — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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