Pharmacokinetic Comparison Of All FK-506 Formulations

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Veloxis Pharmaceuticals
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. Renal transplant recipients, males or females, of 18 years of age or above.

2. Able to participate and willing to give written informed consent and to comply with study visits and restrictions.

3. Able to understand English.

4. Patients having received a primary or secondary renal transplant

Exclusion Criteria:

1. Evidence of acute rejection episode within the past three months prior to screening.

2. Recipients of organ transplants other than kidney.

3. Patients who are known to be HIV positive.