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

September 17, 2014 updated by: Astellas Pharma Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Brno, Czech Republic
      • Hradec Kralove, Czech Republic
      • Olomouc, Czech Republic
      • Ostrava, Czech Republic
  • Hungary
      • Debrecen, Hungary
      • Pecs, Hungary
  • Poland
      • Bialystok, Poland
      • Gdansk, Poland
      • Krakow, Poland
      • Lublin, Poland
      • Warsaw, Poland
      • Wroclaw, Poland
      • Zabrze, Poland
  • Slovakia
      • Banska, Slovakia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Tacrolimus/MMF/steroids throughout the study
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506
Drug: Mycophenolate Mofetil
oral
Other Names:
  • CellCept
Drug: methylprednisolone and prednisone
IV and oral
Other Names:
  • Steroids
EXPERIMENTAL: 2
Tacrolimus/MMF/steroids with MMF reduction from week 7 to 12 and MMF discontinuation at month 3
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506
Drug: Mycophenolate Mofetil
oral
Other Names:
  • CellCept
Drug: methylprednisolone and prednisone
IV and oral
Other Names:
  • Steroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and seriousness of adverse events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (ACTUAL)

August 1, 2004

Study Completion (ACTUAL)

August 1, 2004

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 6, 2008

First Posted (ESTIMATE)

June 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FG-506-02-CEE-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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