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Completed

NCT Number: NCT00693381

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

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: Prograf, FK506

Mycophenolate mofetil

Drug

oral

Other names: CellCept

methylprednisolone and prednisone

Drug

IV and oral

Other names: Steroids

Primary outcomes

  1. Incidence of and time to first biopsy proven acute rejection over the first 6 months post transplantation

    Time frame: 6 months

Secondary outcomes

  1. Incidence and seriousness of adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Acronym: DISTAMP

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 9, 2008
Registry last updated
Sep 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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