Clinical trial NCT02160054: Specified Drug Use-results Survey of Graceptor in Patients With Kidney Transplantation (Switching From Cyclosporine)
Official title: Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Maintenance Phase After Kidney Transplantation
Keywords: tacrolimus
cyclosporine
Graceptor®
kidney transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 289
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are converted to Graceptor® from cyclosporine in the maintenance phase after kidney transplantation.

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


Eligibility 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

Primary outcomes:
measure: Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)
timeFrame: 12 months
Secondary outcomes:
measure: Renal function, hypertension, hyperlipidaemia, other adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site JP00001
city: Chiba
country: Japan
facility: Site JP00015
city: Ehime
country: Japan
facility: Site JP00003
city: Fukuoka
country: Japan
facility: Site JP00029
city: Fukushima
country: Japan
facility: Site JP00009
city: Gifu
country: Japan
facility: Site JP00017
city: Hiroshima
country: Japan
facility: Site JP00002
city: Hokkaido
country: Japan
facility: Site JP00005
city: Hyogo
country: Japan
facility: Site JP00024
city: Ibaraki
country: Japan
facility: Site JP00012
city: Ishikawa
country: Japan
facility: Site JP00020
city: Iwate
country: Japan
facility: Site JP00010
city: Kagawa
country: Japan
facility: Site JP00026
city: Kagoshima
country: Japan
facility: Site JP00030
city: Kanagawa
country: Japan
facility: Site JP00014
city: Kochi
country: Japan
facility: Site JP00027
city: Kumamoto
country: Japan
facility: Site JP00028
city: Kyoto
country: Japan
facility: Site JP00008
city: Mie
country: Japan
facility: Site JP00019
city: Miyagi
country: Japan
facility: Site JP00011
city: Nagasaki
country: Japan
facility: Site JP00006
city: Nara
country: Japan
facility: Site JP00023
city: Niigata
country: Japan
facility: Site JP00013
city: Okayama
country: Japan
facility: Site JP00025
city: Osaka
country: Japan
facility: Site JP00022
city: Saitama
country: Japan
facility: Site JP00016
city: Shizuoka
country: Japan
facility: Site JP00018
city: Tokyo
country: Japan
facility: Site JP00007
city: Wakayama
country: Japan
facility: Site JP00021
city: Yamagata
country: Japan
facility: Site JP00004
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_DIRECTOR
References: