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

Astellas

Status: Completed

Conditions: the Maintenance Phase After Kidney Transplantation

Treatments: Drug: Graceptor®

Study type: Observational

Funder types: Industry

Identifiers

NCT02160054

GRA006

Details and patient eligibility

About

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

Enrollment: 289 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

289 participants in 1 patient group

Group 1

Description:

patients with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ®

Treatment:

Drug: Graceptor®