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

Seoul National University

Status and phase: Completed; Phase 3

Conditions: Tacrolimus; Pharmacokinetics

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT01055964

Tacrobell-01

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Tacrobell

Experimental group

Treatment:

Drug: Tacrolimus

Prograf

Active Comparator group

Treatment:

Drug: Tacrolimus