Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00717379

Collaborator

(none)

Enrollment

Locations

Arms

17.1

Duration (Months)

8.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation Kidney Failure, Chronic Renal Insufficiency, Chronic	Drug: Tacrolimus Drug: Mycophenolate Mofetil Drug: Methylprednisolone or equivalent Drug: Prednisone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Open-Label, Randomized, Multicenter, Parallel-Group Efficacy and Safety Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 steroid regimen 1	Drug: Tacrolimus oral Other Names: Prograf FK506 Drug: Mycophenolate Mofetil oral Other Names: MMF Drug: Methylprednisolone or equivalent oral Drug: Prednisone oral
Experimental: 2 steroid regimen 2	Drug: Tacrolimus oral Other Names: Prograf FK506 Drug: Mycophenolate Mofetil oral Other Names: MMF Drug: Methylprednisolone or equivalent oral Drug: Prednisone oral

Arm

Intervention/Treatment

Active Comparator: 1

steroid regimen 1

Drug: Tacrolimus

oral

Other Names:

Prograf

FK506

Drug: Mycophenolate Mofetil

oral

Other Names:

MMF

Drug: Methylprednisolone or equivalent

oral

Drug: Prednisone

oral

Experimental: 2

steroid regimen 2

Drug: Tacrolimus

oral

Other Names:

Prograf

FK506

Drug: Mycophenolate Mofetil

oral

Other Names:

MMF

Drug: Methylprednisolone or equivalent

oral

Drug: Prednisone

oral

Outcome Measures

Primary Outcome Measures

Incidence and time to first biopsy-proven acute rejection [6 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country	Postal Code
1	Moscow	Russian Federation	115446
2	Moscow	Russian Federation	119992
3	Moscow	Russian Federation	123182
4	Omsk	Russian Federation	644112
5	St. Petersburg	Russian Federation	197110
6	Volzskii	Russian Federation	404120