The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients

Study Identifier:
DFIDM-1701
ClinicalTrials.gov Identifier:
NCT03558373
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Scientific Result Summary
Available Languages: English
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Study Details

Medical Condition
  • Prophylaxis of Kidney Rejection
Study Drug
  • Drug: Immunosuppressive
Date
Jul 2018 - Feb 2020
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Adult (≥ 18 years) recipients of a deceased- or living-donor kidney transplant since maximum 12 months.
  • Recipients with a functioning graft
  • Patients receiving tacrolimus once-daily as part of their IS therapy since minimum 2 months.
  • Patients who have signed informed consent form and privacy form.
  • Patients capable of discernment and able to read and write in Italian language.
Exclusion Criteria
  • Patients received or planned to receive, a non-renal solid organ transplant, a simultaneous pancreas-kidney transplant, or a bone narrow transplant.
  • Patients who already received a kidney transplant (re-transplant).
  • Patients enrolled or planned to be enrolled in any clinical study.
  • Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.
Healthy Volunteers
No

Protocol Summary

Non-adherence is widespread in the transplant community. Addressing issues associated with non-adherence remains a key challenge in transplantation, in part due to the difficulty in assessing its prevalence, as there is currently no 'gold standard' for use in routine clinical practice.

The purpose of this study is to evaluate the non-adherence to immunosuppressive therapy, including tacrolimus once-daily, among Italian kidney transplant recipients receiving. Along with non-adherence evaluation, possible factors related to NA will be investigated (patient-related, condition/disease-related, therapy/treatment-related, etc.).

Study Locations

Location
Status
Location
A.O.U. Consorziale Policlinico
Bari, Italy
Status
N/A
Location
A.O.U. Policlinico S.Orsola Malpighi
Bologna, Italy
Status
N/A
Location
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Status
N/A
Location
A.O.U. Maggiore della Carità
Novara, Italy
Status
N/A
Location
Azienda Ospedaliera di Padova
Padova, Italy
Status
N/A
Location
ARNAS Ospedale Civico
Palermo, Italy
Status
N/A
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