Status:
COMPLETED
Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. ...
Eligibility Criteria
Inclusion
- Patient has an end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation
- Patient is receiving a kidney transplant, from a cadaveric or living donor between 5 and 65 years of age with compatible ABO blood type
Exclusion
- Patient has an immunological high risk, defined as having a most recently measured PRA grade of \>= 50% within the previous six months
- Patient requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation
- Patient requires initial sequential or parallel therapy with immunosuppressive antibody preparation(s)
- Patient or donor is known to be HIV positive
- Patient with malignancy or history of malignancy, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
- Patient has significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, or active peptic ulcer
- Patient is receiving a graft from a non-heart-beating donor
- Cold ischemia time of the donor kidney \>= 40 hours
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00693381
Start Date
February 1 2003
End Date
August 1 2004
Last Update
September 18 2014
Active Locations (14)
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1
Brno, Czechia
2
Hradec Králové, Czechia
3
Olomouc, Czechia
4
Ostrava, Czechia