NCT00717678

Brief Summary

The purpose of this study is to compare the efficacy and safety of Prograf extended release(XL) plus MMF with Prograf plus MMF in de novo kidney transplant recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

5 active sites

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

December 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 17, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

December 17, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

July 16, 2008

Last Update Submit

December 16, 2015

Conditions

Kidney TransplantationTransplantation ImmunologyHost vs Graft Reaction

Keywords

ImmunosuppressantCombination drug therapyGraft lossRandomized controlled trialOpen level method

Outcome Measures

Primary Outcomes (1)

  • The patient and graft survival rates at 6 month post-transplant

    6 months

Secondary Outcomes (3)

  • Efficacy failure at 6-month posttransplant.

    6 months

  • Incidence of biopsy confirmed acute rejection (Banff > 1) at 6 months and 12 months

    6 months and 12 months

  • 1 year patient and graft survival

    1 year

Study Arms (2)

Prograf-XL + MMF

EXPERIMENTAL
Drug: Prograf-XLDrug: MMF

Prograf + MMF

ACTIVE COMPARATOR
Drug: PrografDrug: MMF

Interventions

Prograf-XLDRUG

oral

Also known as: tacrolimus extended release, FK506XL, MR4
Prograf-XL + MMF
PrografDRUG

oral

Also known as: tacrolimus, FK506
Prograf + MMF
MMFDRUG

oral

Also known as: Mycophenolate Mofetil
Prograf + MMFPrograf-XL + MMF

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
  • Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living kidney transplant
  • Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment or upon hospitalization

You may not qualify if:

  • Patient has previously received or is receiving an organ transplant other than a kidney
  • Patient has received a kidney transplant from a non-heart beating donor
  • Patient has received an ABO incompatible donor kidney
  • Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
  • Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
  • Patient has significant liver disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
  • Patient has an uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives
  • Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
  • Patient is receiving everolimus or enteric coated mycophenolic acid at any time during the study
  • Patient has a known hypersensitivity to tacrolimus, mycophenolate mofetil or corticosteroids
  • Patient is pregnant or lactating
  • Patient is unlikely to comply with the visits scheduled in the protocol
  • Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Taichung, 407, Taiwan

Location

Unknown Facility

Tainan, 704, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Unknown Facility

Taipei, 112, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

Related Links

MeSH Terms

Interventions

TacrolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 17, 2008

Study Start

December 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

December 17, 2015

Record last verified: 2015-12

Locations

TW(5)