the Maintenance Phase After Kidney Transplantation
Conditions
Keywords
tacrolimus, cyclosporine, Graceptor®, kidney transplantation
Brief summary
To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine
Interventions
DRUGGraceptor®
oral
Sponsors
Astellas Pharma Inc
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation. * Patients who meet one or more of following criteria 1. Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision 2. Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug 3. Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug 4. Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision 5. Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Renal function, hypertension, hyperlipidaemia, other adverse events | 12 months |
Countries
Japan
Outcome results
None listed