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

Phase 3

Completed

• Conditions: Pharmacokinetics; Tacrolimus
• Interventions: Drug: Tacrolimus

• Registration Number: NCT01055964
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-01-24
• Study First Submitted QC: 2010-01-24
• Study First Posted: 2010-01-26
• Primary Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-24
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tacrobell	Tacrolimus	-
Prograf	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
pharmacokinetics	at postoperative 10~14 days and at postoperative 6 months for crossover study

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of