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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01055964
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics; Tacrolimus	Drug: Tacrolimus	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tacrobell	Drug: Tacrolimus
Active Comparator: Prograf	Drug: Tacrolimus

Outcome Measures

Primary Outcome Measures

1. pharmacokinetics [at postoperative 10~14 days and at postoperative 6 months for crossover study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Principal Investigator: Jongwon Ha, MD, PhD, Seoul National University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT01055964
• Other Study ID Numbers: Tacrobell-01
• First Posted: Jan 26, 2010
• Last Update Posted: May 27, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Tacrolimus

Study Results

No Results Posted as of May 27, 2015