Prevention of Acute Rejection After Kidney Transplantation
Conditions
Keywords
Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium, tacrolimus.
Brief summary
The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.
Interventions
Sponsors
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously; * Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);
Exclusion criteria
Subjects expected to discontinue tacrolimus therapy; * Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline; * Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of biopsy proven acute rejection | — |
| Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms) | — |
| Quality of life related to GI symptoms (GIQLI scale) | — |
| Full blood count | — |
| Gastrointestinal Adverse Events (check-list) | — |
Outcome results
None listed