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NCT01055964 Clinical Trial

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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01055964
Other study ID # Tacrobell-01
Secondary ID
Status Completed
Phase Phase 3
First received January 24, 2010
Last updated May 24, 2015
Start date September 2008

Study information
Verified date May 2015
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers
Gender Both
Age group 19 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Tacrolimus

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary pharmacokinetics at postoperative 10~14 days and at postoperative 6 months for crossover study
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