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OpenTrials
Completed

NCT Number: NCT02160054

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

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

Completed

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Key information

Conditions

the Maintenance Phase After Kidney Transplantation

Sex eligibility

All sexes

Study type

Observational

Primary location

Site JP00010, Numakunai, Iwate, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Decrease in kidney function: GFR (or eGFR) less than 60 mL/min, or investigator's decision
  • Hypertension: systolic/diastolic blood pressure 130/80 mmHg or more or treatment with an antihypertensive drug
  • Hyperlipidaemia: LDL cholesterol 120 mg/dL or more, or treatment with an antihyperlipidemic drug
  • Rejection: antibody mediated rejection by Banff classification borderline changes or more severe, or investigator's decision
  • Other adverse events and patients who cannot continue cyclosporine treatment based on investigator's decision

Treatment and study plan

Graceptor®

Drug

oral

Other names: tacrolimus, FK506

Primary outcomes

  1. Rate of treatment continuation (incidence of rejection, death, graft loss, or adverse event)

    Time frame: 12 months

Secondary outcomes

  1. Renal function, hypertension, hyperlipidaemia, other adverse events

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Specified Drug Use-Results Survey of Graceptor® Capsules 0.5mg, 1 mg, and 5 mg in Kidney Transplant Patients

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2014
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.