Status:
COMPLETED
Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate if the delayed administration of everolimus could reduce the everolimus associated "anti-proliferative complications" (e.g. wound healing disorder) while maint...
Eligibility Criteria
Inclusion
- Recipients of cadaveric kidney transplants
- Patients at risk of DGF defined as one or more of the following:
- Donor age \> 55 years
- Cold ischemic time (CIT) ≥ 24 hours but \< 40 hours
- Second or subsequent renal transplantation
Exclusion
- Patients who have received an investigational drug within 4 weeks of baseline period
- Patients who are recipients of multiple organ transplants, including more than one kidney, or previous transplant with any organ other than kidney
- Patients with body mass index (BMI) \> 32 kg/m2
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT00154297
Start Date
June 1 2005
Last Update
April 4 2011
Active Locations (1)
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1
Novartis
Basel, Switzerland