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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01055964
First Posted: January 26, 2010
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital
  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: None (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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 24, 2010
First Posted: January 26, 2010
Last Update Posted: May 27, 2015
Last Verified: May 2015

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