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

NCT ID: NCT00231764

Last Updated: 2008-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1760 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30
• Study Completion Date: 2008-02-29

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.

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.

Conditions

Kidney Transplantation

Keywords

Renal transplantation; Immunosuppression; Daclizumab; GFR

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

daclizumab

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prof. Philip Halloran, Edmonton, Canada (sponsor)

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

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

UNKNOWN

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Ekberg, Henrik, M.D.

INDIV

Sponsor Role: lead

Principal Investigators

Henrik Ekberg, Prof.

Role: STUDY_CHAIR

Malmo University Hospital, Malmö, Sweden

Philip Halloran, Prof.

Role: STUDY_CHAIR

University of Alberta, Edmonton, Canada

References

Ekberg H, Tedesco-Silva H, Demirbas A, Vitko S, Nashan B, Gurkan A, Margreiter R, Hugo C, Grinyo 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. doi: 10.1056/NEJMoa067411.

Reference Type: DERIVED

PMID: 18094377 (View on PubMed)

Other Identifiers

SYMPHONY

Identifier Type: -

Identifier Source: org_study_id