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

Completed

• Conditions: the Maintenance Phase After Kidney Transplantation
• Interventions: Drug: Graceptor®

• Registration Number: NCT02160054
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-15
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-10
• Primary Completion: 2016-03-31
• Study Completion: 2016-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Graceptor®	patients with kidney transplantation who converted the immunosuppressant from cyclosporine to Graceptor ®

Primary Outcome Measures

Name	Time	Method
Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)	12 months

Secondary Outcome Measures

Name	Time	Method
Renal function, hypertension, hyperlipidaemia, other adverse events	12 months

Trial Locations

Locations (30)

Site JP00015; 🇯🇵 Chiba, Japan

Site JP00017; 🇯🇵 Gifu, Japan

Site JP00003; 🇯🇵 Ehime, Japan

Site JP00009; 🇯🇵 Fukushima, Japan

Site JP00012; 🇯🇵 Ibaraki, Japan

Site JP00020; 🇯🇵 Ishikawa, Japan

Site JP00030; 🇯🇵 Kagoshima, Japan

Site JP00026; 🇯🇵 Kagawa, Japan

Site JP00014; 🇯🇵 Kanagawa, Japan

Site JP00027; 🇯🇵 Kochi, Japan

Site JP00008; 🇯🇵 Kyoto, Japan

Site JP00028; 🇯🇵 Kumamoto, Japan

Site JP00011; 🇯🇵 Miyagi, Japan

Site JP00013; 🇯🇵 Niigata, Japan

Site JP00022; 🇯🇵 Osaka, Japan

Site JP00016; 🇯🇵 Saitama, Japan

Site JP00018; 🇯🇵 Shizuoka, Japan

Site JP00007; 🇯🇵 Tokyo, Japan

Site JP00021; 🇯🇵 Wakayama, Japan

Site JP00019; 🇯🇵 Mie, Japan

Site JP00001; 🇯🇵 Aichi, Japan

Site JP00006; 🇯🇵 Nagasaki, Japan

Site JP00004; 🇯🇵 Yamagata, Japan

Site JP00010; 🇯🇵 Iwate, Japan

Site JP00029; 🇯🇵 Fukuoka, Japan

Site JP00002; 🇯🇵 Hiroshima, Japan

Site JP00005; 🇯🇵 Hokkaido, Japan

Site JP00024; 🇯🇵 Hyogo, Japan

Site JP00025; 🇯🇵 Okayama, Japan

Site JP00023; 🇯🇵 Nara, Japan