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

This study has been completed.
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital Identifier:
First received: January 24, 2010
Last updated: May 24, 2015
Last verified: May 2015
The aim of this study is to identify the pharmacokinetic differences between two oral forms of Tacrolimus and consequent nephrotoxicity.

Condition Intervention Phase
Drug: Tacrolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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
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


Ages Eligible for Study:   19 Years to 65 Years   (Adult)
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
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Please refer to this study by its identifier: NCT01055964

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Jongwon Ha, MD, PhD Seoul National University
  More Information

Responsible Party: Jongwon Ha, Professor, Seoul National University Hospital Identifier: NCT01055964     History of Changes
Other Study ID Numbers: Tacrobell-01
Study First Received: January 24, 2010
Last Updated: May 24, 2015

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 22, 2017