NCT01055964

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2010

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

6.3 years

First QC Date

January 24, 2010

Last Update Submit

May 24, 2015

Conditions

PharmacokineticsTacrolimus

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics

    at postoperative 10~14 days and at postoperative 6 months for crossover study

Study Arms (2)

Tacrobell

EXPERIMENTAL
Drug: Tacrolimus

Prograf

ACTIVE COMPARATOR
Drug: Tacrolimus

Interventions

TacrolimusDRUG
PrografTacrobell

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ABO-compatible renal transplant recipients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Jongwon Ha, MD, PhD

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 24, 2010

First Posted

January 26, 2010

Study Start

September 1, 2008

Primary Completion

December 1, 2014

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

KR(1)