Status:
COMPLETED
SOCRATES: Steroid or Cyclosporine Removal After Transplantation Using Everolimus
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplanted Recipients
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The aim of this study is to assess the safety and efficacy of corticosteroid discontinuation versus cyclosporine micro emulsion discontinuation in recipients receiving reduced exposure cyclosporine mi...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Males and females aged 18-65 years inclusive.
- First time recipients of cadaveric, living unrelated or living related donor kidney transplants.
- Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.
- Exclusion criteria
- Patients who are recipients of multiple organ transplants, including more than one kidney, kidney and pancreas, or previous transplant with any organ other than kidney.
- Patients at high immunological risk of graft loss, indicated by peak PRA \>50% or loss of a previous renal allograft within the first 6 months of transplantation due to acute rejection.
- Patients who have received an investigational drug within 4 weeks prior to the screening visit.
- Presence of any severe allergy or hypersensitivity to drugs similar to everolimus (e.g. antibiotics such as Clindamycin)
- Other protocol-defined inclusion/exclusion criteria may applied
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00371826
Start Date
March 1 2006
End Date
June 1 2012
Last Update
August 19 2013
Active Locations (7)
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1
Royal Prince Alfred Hospital
NSW, Australia
2
Westmead Hospital
NSW, Australia
3
Princess Alexandra Hospital
QLD, Australia
4
Monash Medical Centre
Sale, Australia