Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
NCT ID: NCT00717379
Last Updated: 2009-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2007-05-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
steroid regimen 1
Tacrolimus
oral
Mycophenolate Mofetil
oral
Methylprednisolone or equivalent
oral
Prednisone
oral
2
steroid regimen 2
Tacrolimus
oral
Mycophenolate Mofetil
oral
Methylprednisolone or equivalent
oral
Prednisone
oral
Interventions
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Tacrolimus
oral
Mycophenolate Mofetil
oral
Methylprednisolone or equivalent
oral
Prednisone
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma Europe BV
Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
ZAO Astellas Pharma Russia
Locations
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Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Omsk, , Russia
Saint Petersburg, , Russia
Volzskii, , Russia
Countries
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Other Identifiers
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PRG-EC-2R01
Identifier Type: -
Identifier Source: org_study_id
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