Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)

• Status: Completed
• Trial end date: 2016-03-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of Graceptor ® in patients with kidney transplantation when converted from cyclosporine

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Cyclosporine; Cyclosporins; Tacrolimus

Criteria

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