To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Hepatic function tests (ALT/AST) after 12 months treatment.
Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
Glomerular filtration rate and by proteinuria after 12 months treatment.
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 between the two investigational groups.
Viral load (HCV RNA) between both groups at 12 months.
Bone density at 12 months in both groups.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.