We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00231764
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : April 24, 2008
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: daclizumab Phase 4

Detailed Description:

The purpose of the SYMPHONY study is to compare four different immunosuppressive regimens. They are each given for one year. The following four combinations are tested in four groups of patients:

  • Group A: Cyclosporine in a normal dosage, mycophenolate mofetil (MMF) and corticosteroids
  • Group B: Daclizumab in the first two months after transplantation, cyclosporine in a lower dosage compared to group A, mycophenolate mofetil (MMF) and corticosteroids
  • Group C: Daclizumab in the first two months after transplantation, tacrolimus in low dosage, mycophenolate mofetil (MMF) and corticosteroids
  • Group D: Daclizumab in the first two months after transplantation, sirolimus in a low dosage, mycophenolate mofetil (MMF) and corticosteroids.

All drugs of the four immunosuppressive regimes are approved by the Health Authorities in the participating country for use in kidney transplantation. The regimen administered to the patients in Group A represents a standard treatment, currently given with success to many transplant patients in a number of countries in the world. The treatments in Groups B, C and D are experimental in the sense that either the doses administered are lower than the ones used before and/or the combination of drugs is experimental. Nevertheless, there are results of scientific studies indicating that they are all effective alternatives and that they might have advantages compared to the standard immunosuppressive regimen, in particular as far as their safety (side effects, long-term toxicity) is concerned. However, from the previous clinical experience, it is not yet clear which regimen offers the most advantages for the patients. To find this out, in SYMPHONY the four regimens are administered to the four groups of patients (A-D) and the results in the different groups will be compared.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Evaluating Safety and Efficacy of MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Combination With Low-Dose CsA, Tac or Sir in Comparison to Current Standard Immunosuppression (MMF, CsA and Corticosteroids) in Renal Tx
Study Start Date : November 2002
Primary Completion Date : May 2006
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation

Secondary Outcome Measures :
  1. Acute rejection rate at 6 and 12 months, patient and graft survival rates at 12 months
  2. Treatment failure during the first twelve months
  3. Time to first acute rejection
  4. Patient and graft survival at 6 and 12 months posttransplant
  5. Calculated GFR using the Cockcroft-Gault formula during the study and measured GFR at month 12
  6. Incidence of Delayed Graft Function (DGF)
  7. Safety Parameters:
  8. Clinical assessments, vital signs, laboratory analyses, adverse events, opportunistic infections, malignancies, and deaths
  9. Incidence of failure to achieve primary closure of transplant surgical wound at 2 weeks
  10. Incidence of lymphocele requiring intervention in the first 6 months posttransplant

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients between 18 - 75 years
  • Recipients of single-organ renal primary allograft or second renal transplants (provided that the previous graft was not lost from acute rejection within the first year) from living or cadaver donors
  • Patients who provide written informed consent.

Exclusion Criteria:

  • PRA > 20% within 6 months prior to enrollment
  • Cold ischemia time > 30 hours
  • Previous treatment with daclizumab
  • History of malignancy (except localized skin cancer)
  • Active peptic ulcer disease.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00231764

Sponsors and Collaborators
Ekberg, Henrik, M.D.
Prof. Philip Halloran, Edmonton, Canada (sponsor)
Prof. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member)
Prof. Pierre Daloze, Montréal, Canada (Steering Committee Member)
Prof. Thomas C. Pearson, Atlanta, USA (Steering Committee Member)
Prof. Ulrich Frei, Berlin, Germany (Steering Committee Member)
Prof. Flavio Vincenti, San Francisco, USA (Ass. Steering Committee Member)
Prof. Josep Grinyo, Barcelona, Spain (Ass. Steering Committee Member)
Hoffmann-La Roche
Study Chair: Henrik Ekberg, Prof. Malmo University Hospital, Malmö, Sweden
Study Chair: Philip Halloran, Prof. University of Alberta, Edmonton, Canada
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00231764     History of Changes
Other Study ID Numbers: SYMPHONY
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: April 24, 2008
Last Verified: April 2008

Keywords provided by Ekberg, Henrik, M.D.:
Renal transplantation

Additional relevant MeSH terms:
Immunoglobulin G
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs