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
  Purpose

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 Intervention Phase
Kidney Transplantation
Drug: daclizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ekberg, Henrik, M.D.:

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

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1760
Study Start Date: November 2002
Study Completion Date: February 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Henrik Ekberg, Prof. Malmo University Hospital, Malmö, Sweden
Study Chair: Philip Halloran, Prof. University of Alberta, Edmonton, Canada
  More Information

No publications provided by Ekberg, Henrik, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00231764     History of Changes
Other Study ID Numbers: SYMPHONY
Study First Received: September 30, 2005
Last Updated: April 22, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Ministry for Health and Women
Belgium: Ministere de la Protection de la Consommation, de la Santé Publique et de l'Environnement
Brazil: National Health Surveillance Agency
Canada: Health Canada, Health Products and Food Branch, Biologics and Genetic Therapies Directorate
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Greece: National Drug Organization (EOF).
Israel: Israeli Health Ministry Pharmaceutical Administration
Poland: Urząd Rejestracji Produktów Leczniczych, Wyrobów Leczniczych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices and Biocides)
Spain: Ministerio de Sanidad y Consumo, Subdirección General de Medicamentos de uso Humano
Sweden: Medical Products Agency
Turkey: Ministry of Health
UK: North Wales Health Authority

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

Additional relevant MeSH terms:
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014