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

This study is currently recruiting participants. (see Contacts and Locations)
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
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

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 September 22, 2014