Clinical trial NCT00693381: Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation
Official title: An Open, Multicentre, Randomised, Parallel Group Pilot-Study to Compare Safety and Efficacy of Discontinuation of Mycophenolate Mofetil From a Tacrolimus/MMF/Steroid Triple Regimen Following Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Transplantation
Graft Rejection
Renal Transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 152
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: 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. For the others MMF remained at initial dose.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation
timeFrame: 6 months
Secondary outcomes:
measure: Incidence and seriousness of adverse events
timeFrame: 6 months
Other outcomes:
Locations:
city: Brno
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Ostrava
country: Czech Republic
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Bialystok
country: Poland
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Warsaw
country: Poland
city: Wroclaw
country: Poland
city: Zabrze
country: Poland
city: Banska
country: Slovakia
Study officials:
affiliation: Astellas Pharma Europe B.V.
name: Central Contact
role: STUDY_CHAIR
References:
citation: Sulowicz W, Bachleda P, Rydzewski A, Rutkowski B, Szakaly P, Asztalos L, Samlik J, Lackova E, Ksiazek A, Studenik P, Mysliwiec M, Hruby Z, Navratil P, Gumprecht J. Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized, multicentre study. Transpl Int. 2007 Mar;20(3):230-7. doi: 10.1111/j.1432-2277.2006.00421.x.