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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693381
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Tacrolimus Drug: Mycophenolate Mofetil Drug: methylprednisolone and prednisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2003
Actual Primary Completion Date : August 2004
Actual Study Completion Date : August 2004

Arm Intervention/treatment
Experimental: 1
Tacrolimus/MMF/steroids throughout the study
Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506

Drug: Mycophenolate Mofetil
Other Name: CellCept

Drug: methylprednisolone and prednisone
IV and oral
Other Name: Steroids

Experimental: 2
Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506

Drug: Mycophenolate Mofetil
Other Name: CellCept

Drug: methylprednisolone and prednisone
IV and oral
Other Name: Steroids

Primary Outcome Measures :
  1. Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Incidence and seriousness of adverse events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00693381

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Czech Republic
Brno, Czech Republic
Hradec Kralove, Czech Republic
Olomouc, Czech Republic
Ostrava, Czech Republic
Debrecen, Hungary
Pecs, Hungary
Bialystok, Poland
Gdansk, Poland
Krakow, Poland
Lublin, Poland
Warsaw, Poland
Wroclaw, Poland
Zabrze, Poland
Banska, Slovakia
Sponsors and Collaborators
Astellas Pharma Inc
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Study Chair: Central Contact Astellas Pharma Europe B.V.
Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT00693381    
Other Study ID Numbers: FG-506-02-CEE-01
First Posted: June 9, 2008    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by Astellas Pharma Inc:
Graft Rejection
Renal Transplantation
Additional relevant MeSH terms:
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Mycophenolic Acid
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents