Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00717379
• Other study ID #: PRG-EC-2R01
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2008
• Last updated: April 13, 2009
• Start date: May 2007
• Est. completion date: October 2008

Study information

• Verified date: April 2009
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Kidney Transplantation
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Tacrolimus
oral
• Mycophenolate Mofetil
oral
• Methylprednisolone or equivalent
oral
• Prednisone
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and time to first biopsy-proven acute rejection		6 months	Yes
Secondary	Overall frequency of acute rejection episodes within 6 months post transplantation		6 months	Yes
Secondary	Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation		6 months	Yes
Secondary	Incidence of and time to first corticosteroid-resistant acute rejection		6 months	Yes
Secondary	Subject and graft survival		6 months	Yes