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

January 24, 2010
July 18, 2013
September 2008
December 2014   (final data collection date for primary outcome measure)
pharmacokinetics [ Time Frame: at postoperative 10~14 days and at postoperative 6 months for crossover study ]
Same as current
Complete list of historical versions of study NCT01055964 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients
a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
  • Pharmacokinetics
  • Tacrolimus
Drug: Tacrolimus
  • Experimental: Tacrobell
    Intervention: Drug: Tacrolimus
  • Active Comparator: Prograf
    Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
Not Provided
Contact: Jongwon Ha, MD, PhD +82-2-2072-2991 jwhamd@snu.ac.kr
Korea, Republic of
 
NCT01055964
Tacrobell-01
Yes
Jongwon Ha, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Jongwon Ha, MD, PhD Seoul National University
Seoul National University Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP