Status:
TERMINATED
Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Renal Transplantation
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief Summary
This study wants to address whether a calcineurin-inhibitor (CNI)-free regimen six weeks after transplantation for Eurotransplant Senior Program (ESP) patients is as safe and well tolerated as standar...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients receiving a primary kidney from a donor aged \> 65 years
- In the Eurotransplant Senior Program
- Recipients of de novo cadaveric kidney transplants
- Exclusion criteria:
- Multi-organ recipients (e.g., kidney and pancreas)
- Patients receiving a kidney from a non-heart beating donor
- Patients who are recipients of A-B-O incompatible transplants
- Patients with already existing antibodies against the HLA-type of the receiving transplant
- Patients who have received an investigational immunosuppressive drug within four weeks prior to study entry (Baseline visit 1)
- Patients with thrombocytopenia, with an absolute neutrophil count of \< 1,500/mm³ or leucopenia or hemoglobin \< 6 g/dL
- Patients who are HIV, HCV RNA, or Hepatitis B surface antigen positive
- Evidence of severe liver disease
- Females at randomization who will be not considered post-menopausal
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT00956293
Start Date
July 1 2009
End Date
March 1 2013
Last Update
June 6 2014
Active Locations (9)
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1
Novartis Investigative Site
Aachen, Germany, 52074
2
Novartis Investigative Site
Berlin, Germany, 10117
3
Novartis Investigative Site
Düsseldorf, Germany, 40225
4
Novartis Investigative Site
Essen, Germany, 45147