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

NCT00231764 | Completed Phase 4

• 1 other identifier: SYMPHONY
• Study Type: interventional
• Target: 1,760
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Transplantation

Keywords

Renal transplantation; Immunosuppression; Daclizumab; GFR

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (10)

• 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

Interventions

daclizumab DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ekberg, Henrik, M.D.: lead
• Prof. Philip Halloran, Edmonton, Canada (sponsor): collaborator
• Prof. Yves Vanrenterghem, Leuven, Belgium (Steering Committee Member): collaborator
• Prof. Pierre Daloze, Montréal, Canada (Steering Committee Member): collaborator
• Prof. Thomas C. Pearson, Atlanta, USA (Steering Committee Member): collaborator
• Prof. Ulrich Frei, Berlin, Germany (Steering Committee Member): collaborator
• Prof. Flavio Vincenti, San Francisco, USA (Ass. Steering Committee Member): collaborator
• Prof. Josep Grinyo, Barcelona, Spain (Ass. Steering Committee Member): collaborator
• Hoffmann-La Roche: collaborator

Related Publications (1)

• 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.

  PMID: 18094377 DERIVED

MeSH Terms

Interventions

Daclizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Henrik Ekberg, Prof.

  Malmo University Hospital, Malmö, Sweden

  STUDY CHAIR

• Philip Halloran, Prof.

  University of Alberta, Edmonton, Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: November 1, 2002
• Primary Completion: May 1, 2006
• Study Completion: February 1, 2008
• Last Updated: April 24, 2008

Record last verified: 2008-04