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Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status

Completed

Conditions

Renal Transplant

Study type

Observational

Funder types

Industry

Identifiers

NCT02581644
IM103-367

Details and patient eligibility

About

The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

Full description

3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient survey (cohort 1):
  • Patients has taken belatacept within the previous 3 months for renal transplantation
  • Patient is over 18 years of age
  • HCP survey (cohort 2):
  • Physician or nurses working in nephrology centers, with at least 1 patient taking belatacept in the previous 6 months for renal transplantation (by prescribing, administering or by follow up)
  • Retrospective chart review study (cohort 3):
  • Patient survey questionnaire received, Informed Consent Form (ICF) signed (if required)

Exclusion criteria

  • Patient survey:
  • Patient has participated in a clinical trial for their renal condition in the previous 12 months
  • Currently an employee of BMS
  • HCP survey:
  • Physicians or nurse who have recruited patients for the Patient survey
  • Currently an employee of BMS

Trial design

63 participants in 3 patient groups

Patients survey
Description:
Adult patients treated with belatacept for renal transplantation
HCP survey
Description:
HCP with at least 1 patient taking belatacept
Retrospective chart review study
Description:
Adult patients treated with belatacept for renal transplantation

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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