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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01055964
First received: January 24, 2010
Last updated: May 24, 2015
Last verified: May 2015
  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
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 Jongwon Ha, 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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055964

Locations
Korea, Republic of
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
  More Information

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: May 24, 2015

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 28, 2017