Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
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
Information provided by:
Ekberg, Henrik, M.D.
ClinicalTrials.gov Identifier:
NCT00231764
First received: September 30, 2005
Last updated: April 22, 2008
Last verified: April 2008

September 30, 2005
April 22, 2008
November 2002
May 2006   (final data collection date for primary outcome measure)
GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
Same as current
Complete list of historical versions of study NCT00231764 on ClinicalTrials.gov Archive Site
  • Acute rejection rate at 6 and 12 months, patient and graft survival rates at 12 months
  • Treatment failure during the first twelve months
  • Time to first acute rejection
  • Patient and graft survival at 6 and 12 months posttransplant
  • Calculated GFR using the Cockcroft-Gault formula during the study and measured GFR at month 12
  • Incidence of Delayed Graft Function (DGF)
  • Safety Parameters:
  • Clinical assessments, vital signs, laboratory analyses, adverse events, opportunistic infections, malignancies, and deaths
  • Incidence of failure to achieve primary closure of transplant surgical wound at 2 weeks
  • Incidence of lymphocele requiring intervention in the first 6 months posttransplant
  • - Acute rejection rate at 6 and 12 months, patient and graft survival rates at 12 months
  • - Treatment failure during the first twelve months
  • - Time to first acute rejection
  • - Patient and graft survival at 6 and 12 months posttransplant
  • - Calculated GFR using the Cockcroft-Gault formula during the study and measured GFR at month 12
  • - Incidence of Delayed Graft Function (DGF)
  • Safety Parameters:
  • - Clinical assessments, vital signs, laboratory analyses, adverse events, opportunistic infections, malignancies, and deaths
  • - Incidence of failure to achieve primary closure of transplant surgical wound at 2 weeks
  • - Incidence of lymphocele requiring intervention in the first 6 months posttransplant
Not Provided
Not Provided
 
MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Kidney Transplantation
Drug: daclizumab
Not Provided
Ekberg H, Tedesco-Silva H, Demirbas A, Vítko S, Nashan B, Gürkan A, Margreiter R, Hugo C, Grinyó JM, Frei U, Vanrenterghem Y, Daloze P, Halloran PF; ELITE-Symphony Study. Reduced exposure to calcineurin inhibitors in renal transplantation. N Engl J Med. 2007 Dec 20;357(25):2562-75.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1760
February 2008
May 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00231764
SYMPHONY
Not Provided
Not Provided
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
Ekberg, Henrik, M.D.
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP