Status:
COMPLETED
Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafte...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Male and female patients of any race 18 years or older
- Adult recipients of a kidney transplant from a deceased or from a living donor
- Recipients of a functioning Kidney:. Graft must be functional no later than 36h after transplantation.
- Exclusion criteria
- Need for medication prohibited by the protocol
- Patients or donors infected with hepatitis B or C, or with HIV.
- Patients with a history of cancer
- Patients with severe systemic infections Patients with heart diseases (own or family history) which are associated with an increased risk for arrhythmias.
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT00403416
Start Date
October 1 2006
End Date
May 1 2008
Last Update
December 17 2020
Active Locations (28)
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1
University of California, San Francisco
San Francisco, California, United States, 94143-0780
2
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106-5048
3
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792-7375
4
QE II Health Sciences Center
Halifax, Canada, B3H 1V7