Clinical trial NCT00717379: Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
Official title: Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Keywords: Organ Transplantation
Tacrolimus
Prograf
Kidney
Immunosuppression
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-07-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence and time to first biopsy-proven acute rejection
timeFrame: 6 months
Secondary outcomes:
measure: Overall frequency of acute rejection episodes within 6 months post transplantation
timeFrame: 6 months
measure: Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation
timeFrame: 6 months
measure: Incidence of and time to first corticosteroid-resistant acute rejection
timeFrame: 6 months
measure: Subject and graft survival
timeFrame: 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Omsk
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Volzskii
country: Russian Federation
Study officials:
affiliation: ZAO Astellas Pharma Russia
name: Central Contact
role: STUDY_DIRECTOR
References: