Kidney TransplantationPhase 4NCT00231764
MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients
A Phase 4 study testing daclizumab in people with Kidney Transplantation, run by Ekberg, Henrik, M.D..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- daclizumab
- How many people
- 1,760 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Feb 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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
- Being tested
- daclizumab
- Keywords
- Renal transplantation, Immunosuppression, Daclizumab, GFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
daclizumabDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startNov 2002
- Primary completionMay 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,760 participants
Sponsor and investigators
- Lead sponsor
- Ekberg, Henrik, M.D.
- 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
- Investigators
- Henrik Ekberg, Prof., Study chair, Malmo University Hospital, Malmö, SwedenPhilip Halloran, Prof., Study chair, University of Alberta, Edmonton, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231764
- Sponsor's protocol ID
- SYMPHONY
- Status last verified
- Apr 2008
- First submitted
- 30 Sep 2005
- Last updated
- 24 Apr 2008
- Results posted
- No
Publications
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.
PubMed 18094377
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00231764
- Acronym / sponsor ID
- SYMPHONY
- Conditions
- Kidney Transplantation
- Keywords
- Renal transplantation, Immunosuppression, Daclizumab, GFR
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,760 participants
- Lead sponsor
- Ekberg, Henrik, M.D.
- 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
- Study start
- Nov 2002
- Primary completion
- May 2006 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 4 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| daclizumab | Drug | – |
Primary outcome
GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2008.
- Derived from this study: PubMed 18094377Ekberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Ekberg, Prof. study chair
Malmo University Hospital, Malmö, Sweden
Philip Halloran, Prof. study chair
University of Alberta, Edmonton, Canada
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing daclizumab in people with Kidney Transplantation, run by Ekberg, Henrik, M.D..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GFR calculated from the serum creatinine with the Cockcroft-Gault formula at 12 months posttransplantation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00231764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2008.