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MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients

NCT00231764 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1760

Last updated 2008-04-24

No results posted yet for this study

Summary

To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in combination with low-dose cyclosporine, tacrolimus, or sirolimus, and compare it to that of renal transplant recipients receiving standard immunosuppression with mycophenolate mofetil, normal dose cyclosporine and corticosteroids.

Conditions

  • Kidney Transplantation

Interventions

DRUG

daclizumab

Sponsors & Collaborators

  • Prof. Philip Halloran, Edmonton, Canada (sponsor)

    collaborator UNKNOWN

  • Prof. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member)

    collaborator UNKNOWN

  • Prof. Pierre Daloze, Montréal, Canada (Steering Committee Member)

    collaborator UNKNOWN

  • Prof. Thomas C. Pearson, Atlanta, USA (Steering Committee Member)

    collaborator UNKNOWN

  • Prof. Ulrich Frei, Berlin, Germany (Steering Committee Member)

    collaborator UNKNOWN

  • Prof. Flavio Vincenti, San Francisco, USA (Ass. Steering Committee Member)

    collaborator UNKNOWN

  • Prof. Josep Grinyo, Barcelona, Spain (Ass. Steering Committee Member)

    collaborator UNKNOWN

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Ekberg, Henrik, M.D.

    lead INDIV

Principal Investigators

  • Henrik Ekberg, Prof. · Malmo University Hospital, Malmö, Sweden

  • Philip Halloran, Prof. · University of Alberta, Edmonton, Canada

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2006-05-31
Completion
2008-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231764 on ClinicalTrials.gov