Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

Kidney Transplantation Clinical Trial

— DISTAMP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693381
• Other study ID #: FG-506-02-CEE-01
• Status: Completed
• Phase: Phase 3
• First received: June 3, 2008
• Last updated: September 17, 2014
• Start date: February 2003
• Est. completion date: August 2004

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsCzech Republic: State Institute for Drug ControlHungary: National Institute of PharmacySlovakia: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Tacrolimus
oral
• Mycophenolate Mofetil
oral
• methylprednisolone and prednisone
IV and oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Czech Republic,  Hungary,  Poland,  Slovakia, 

References & Publications (1)

Sulowicz W, Bachleda P, Rydzewski A, Rutkowski B, Szakály P, Asztalos L, Samlik J, Lacková E, Ksiazek A, Studenik P, Mysliwiec M, Hruby Z, Navrátil 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation		6 months	No
Secondary	Incidence and seriousness of adverse events		6 months	No

External Links

•   Link to Results on JAPIC - enter 140599 in the JapicCTI-RNo. field