6-month, Open-label, Randomized, Multicenter, Prospective, Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
Phase 4
65 Years
N/A
65 Years
N/A
Open (Enrolling)
Both
Renal Transplantation
Both
Renal Transplantation
Trial Information
6-month, Open-label, Randomized, Multicenter, Prospective, Controlled Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
renal function assessed by glomerular filtration rate - Cockcroft-Gault method
Outcome Time Frame:
at month 6
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CRAD001ADE19
NCT ID:
NCT00956293
Start Date:
July 2009
Completion Date:
Related Keywords:
- Renal Transplantation
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