We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
January 24, 2010
January 26, 2010
May 27, 2015
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
Intervention Model: Crossover Assignment
Masking: None (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.
 
Completed
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
Sexes Eligible for Study: All
19 Years to 65 Years   (Adult)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01055964
Tacrobell-01
Yes
Not Provided
Not Provided
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
May 2015

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