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Completed

NCT Number: NCT00231764

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Daclizumab

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ekberg, Henrik, M.D.

Indiv

Collaborators

  • Hoffmann-La Roche
  • Prof. Flavio Vincenti, San Francisco, USA (Ass. Steering Committee Member)
  • Prof. Josep Grinyo, Barcelona, Spain (Ass. Steering Committee Member)
  • Prof. Philip Halloran, Edmonton, Canada (sponsor)
  • 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. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member)

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2006
Study completion
2008
First posted
Oct 4, 2005
Registry last updated
Apr 24, 2008

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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