a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.

• Phase: Phase 3

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• ABO-compatible renal transplant recipients

Exclusion Criteria:

• multi-organ transplant

• HIV(+) donor or recipients

• history of malignancy other than skin cancer (except completely cured basal cell ca or squamous cell ca)

• more than three-fold increase in AST or ALT level for 28 days

• pregnancy

• lactation