NCT00717379

Brief Summary

To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2007

Geographic Reach
1 country

6 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

May 1, 2007

Completed
1.2 years 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
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

1.4 years

First QC Date

July 16, 2008

Last Update Submit

April 13, 2009

Conditions

Kidney TransplantationKidney Failure, ChronicRenal Insufficiency, Chronic

Keywords

Organ TransplantationTacrolimusPrografKidneyImmunosuppression

Outcome Measures

Primary Outcomes (1)

  • Incidence and time to first biopsy-proven acute rejection

    6 months

Secondary Outcomes (4)

  • Overall frequency of acute rejection episodes within 6 months post transplantation

    6 months

  • Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation

    6 months

  • Incidence of and time to first corticosteroid-resistant acute rejection

    6 months

  • Subject and graft survival

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

steroid regimen 1

Drug: TacrolimusDrug: Mycophenolate MofetilDrug: Methylprednisolone or equivalentDrug: Prednisone

2

EXPERIMENTAL

steroid regimen 2

Drug: TacrolimusDrug: Mycophenolate MofetilDrug: Methylprednisolone or equivalentDrug: Prednisone

Interventions

TacrolimusDRUG

oral

Also known as: Prograf, FK506
12
Mycophenolate MofetilDRUG

oral

Also known as: MMF
12
Methylprednisolone or equivalentDRUG

oral

12
PrednisoneDRUG

oral

12

Eligibility Criteria

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

You may qualify if:

  • Female subject of childbearing potential must have a negative serum pregnancy test at enrolment and must agree to maintain effective birth control during the study
  • Has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
  • Subject is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible AB0 blood type

You may not qualify if:

  • Pregnant woman or breast-feeding mother
  • Has an immunological high risk, defined as having a most recently measured PRA grade of \> 50% within the previous six months
  • Known allergy to the study drug or any of its components
  • Requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
  • Requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
  • Subject or donor is known to be HIV positive
  • Has significant liver disease, defined as having during the past 28 days continuously elevated ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
  • Diagnosis of malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
  • Has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
  • Previously received or is receiving an organ transplant other than kidney
  • Receiving a graft from a non-heart-beating donor
  • Cold ischemia time of the donor kidney \>30 hours
  • Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Moscow, 115446, Russia

Location

Unknown Facility

Moscow, 119992, Russia

Location

Unknown Facility

Moscow, 123182, Russia

Location

Unknown Facility

Omsk, 644112, Russia

Location

Unknown Facility

Saint Petersburg, 197110, Russia

Location

Unknown Facility

Volzskii, 404120, Russia

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, Chronic

Interventions

TacrolimusMycophenolic AcidMethylprednisolonePrednisone

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienediols

Study Officials

  • Central Contact

    ZAO Astellas Pharma Russia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 17, 2008

Study Start

May 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

RU(6)