Status:
COMPLETED
Everolimus in de Novo Kidney Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in compa...
Eligibility Criteria
Inclusion
- Key Inclusion criteria:
- Patients who are willing and able to participate in the study and who provide written informed consent before performing any study related procedure;
- Men or women ≥18 years at transplant;
- Recipients of 1st or 2nd single kidney transplant from deceased donor or living unrelated/related donor \> 14 years;
- Key Exclusion criteria:
- Patients who are recipients of multiple organs transplant, including two kidneys;
- Historical or current peak PRA \> 50%. Patients with already existing antibodies against the donor;
- Thrombocytopenia (platelets \< 75,000/mm³), absolute neutrophil count \<1,500/mm³, leucopenia (leucocytes \< 2,500/mm³) or hemoglobin \< 7 g/dL;
- Body mass index (BMI) \> 30 Kg/m2;
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT01410448
Start Date
November 1 2011
End Date
December 1 2015
Last Update
June 16 2017
Active Locations (22)
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1
Novartis Investigative Site
Ancona, AN, Italy, 60126
2
Novartis Investigative Site
Coppito, AQ, Italy, 67100
3
Novartis Investigative Site
Bari, BA, Italy, 70124
4
Novartis Investigative Site
Bologna, BO, Italy, 40138