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

This study is currently recruiting participants.
Verified July 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01055964
First received: January 24, 2010
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Pharmacokinetics
Tacrolimus
Drug: Tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: at postoperative 10~14 days and at postoperative 6 months for crossover study ]

Estimated Enrollment: 80
Study Start Date: September 2008
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrobell Drug: Tacrolimus
Active Comparator: Prograf Drug: Tacrolimus

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055964

Contacts
Contact: Jongwon Ha, MD, PhD +82-2-2072-2991 jwhamd@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Hyejin Hong    +82-2-2072-3550      
Sub-Investigator: Sang Il Min, MD         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Jongwon Ha, MD, PhD Seoul National University
  More Information

No publications provided

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01055964     History of Changes
Other Study ID Numbers: Tacrobell-01
Study First Received: January 24, 2010
Last Updated: July 18, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014