Kidney Transplantation
Conditions
Keywords
MPA, Kidney Transplantation, Acute rejection, Kidney function
Brief summary
The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
Interventions
DRUGMyfortic
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18 to 75 years. * Recipients of first, heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with Simulect® and Neoral® as primary immunosuppression.
Exclusion criteria
* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ. * Kidneys from non-heart beating donors or HLA identical living related donors. * ABO incompatibility against the donor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculated glomerular filtration rate after 12 months treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of death, graft loss, biopsy-proven acute rejection after 3 and 12 months. | — |
| Patient and graft survival after 12 months. | — |
| Incidence of AEs and SAEs after 3 and 12 months. | — |
| Blood pressure, lipids and glucose profiles after 3 and 12 months. | — |
| Percentage of patients free of steroids at 12 months | — |
Countries
Argentina, Australia, Brazil, Canada, Germany, Italy, Malaysia, New Zealand, Singapore, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed