NCT00481819

Brief Summary

The patients about to undergo kidney transplantation will be randomized to one of the following two group: Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

9 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

First Submitted

Initial submission to the registry

May 31, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 4, 2007

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.7 years

First QC Date

May 31, 2007

Last Update Submit

February 23, 2016

Conditions

Kidney Transplantation

Keywords

Kidney TransplantationTacrolimusMethylprednisolonePrednisoloneMycophenolate Mofetil

Outcome Measures

Primary Outcomes (1)

  • Event rate of patients with acute rejections

    12 weeks

Secondary Outcomes (3)

  • Incidence of and time to acute rejections

    12 Weeks

  • Overall frequency of acute rejections

    12 Weeks

  • Rate of patient and graft survival following transplantation

    12 Weeks

Study Arms (2)

1

EXPERIMENTAL

In combination with MMF and steroids

Drug: FK506MRDrug: Mycophenolate MofetilDrug: MethylprednisoloneDrug: Prednisolone

2

ACTIVE COMPARATOR

In combination with MMF and steroids

Drug: PrografDrug: Mycophenolate MofetilDrug: MethylprednisoloneDrug: Prednisolone

Interventions

FK506MRDRUG

oral

Also known as: Advagraf, Tacrolimus modified-release, MR4
1
PrografDRUG

oral

Also known as: tacrolimus, FK506
2
Mycophenolate MofetilDRUG

oral

Also known as: MMF
12
MethylprednisoloneDRUG

oral

12
PrednisoloneDRUG

oral

12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent with the date of the patient must be obtained.
  • Patient between 18-70 years of age receiving the primary kidney.
  • Female patients must have a negative pregnancy test prior to the enrolment.
  • Female patients of child bearing potential must agree to practice effective birth control during the study.

You may not qualify if:

  • Kidney re-transplantation patients or received an organ transplantation other than a kidney.
  • PRA\>10% in the previous 6 months.
  • Patient who need antibody induction therapy.
  • Patient with significant liver disease, defined as having continuously elevated \>2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
  • Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
  • Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
  • Patient is HIV or HBsAg positive.
  • Patient is allergic to Prograf or macrolide antibiotics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

3 Sites

Beijing, Beijing Municipality, China

Location

Unknown Facility

Fuzhou, Fujian, China

Location

2 Sites

Guangzhou, Guangdong, China

Location

Unknown Facility

Wuhan, Hubei, China

Location

Unknown Facility

Changsha, Hunan, China

Location

Unknown Facility

Shenyang, Liaoning, China

Location

2 Sites

Shanghai, Shanghai Municipality, China

Location

Unknown Facility

Chongqing, Sichuan, China

Location

Unknown Facility

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

TacrolimusMycophenolic AcidMethylprednisolonePrednisolone

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Prof. Ao Jianhua

    Department of Urologic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 4, 2007

Study Start

July 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

CN(9)