Status:
COMPLETED
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycoph...
Eligibility Criteria
Inclusion
- Patient who had received a primary or secondary kidney transplant
- Patients who were willing and from whom written informed consent was obtained
- kidney allograft with a cold ischemia time (CIT) \< 30 hours
- negative pregnancy test prior to study enrollment
Exclusion
- -Multi-organ recipients
- former Graft loss due to immunological reasons
- Patients who received a kidney from a non-heart beating donor
- A-B-0 incompatible transplants
- a current Panel Reactive Antibody (PRA) level of \> 20%
- existing antibodies against the HLA-type of the receiving transplant
- a known hypersensitivity/contraindication to any of the immunosuppressants
- Use of other investigational drugs
- Patients with thrombocytopenia (platelets \< 100,000/mm³), with an absolute neutrophil count of \< 2,000/mm³ or leucopenia (leucocytes \< 3,000/mm³), or hemoglobin \< 8 g/dL
- significant mental illness
- history of malignancy during the last five years
- HIV positive
- uncontrolled hypercholesterolemia or hypertriglyceridemia
- drug or alcohol abuse
- pregnant or breast feeding women
Key Trial Info
Start Date :
December 27 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 23 2016
Estimated Enrollment :
612 Patients enrolled
Trial Details
Trial ID
NCT01843348
Start Date
December 27 2012
End Date
March 23 2016
Last Update
May 1 2017
Active Locations (27)
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1
Novartis Investigative Site
Poitiers, France, France, 86000
2
Novartis Investigative Site
Bordeaux, France, 33076
3
Novartis Investigative Site
Brest, France, 29200
4
Novartis Investigative Site
Créteil, France, 94010