Clinical trial NCT03558373: The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients
Official title: The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Keywords: adherence
tacrolimus
once-daily
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kidney transplant recipients

Brief 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.).


Eligibility criteria: Inclusion criteria:

1. Adult (≥ 18 years) recipients of a deceased- or living-donor kidney transplant since maximum 12 months.
2. Recipients with a functioning graft
3. Patients receiving tacrolimus once-daily as part of their IS therapy since minimum 2 months.
4. Patients who have signed informed consent form and privacy form.
5. Patients capable of discernment and able to read and write in Italian language.

Exclusion criteria:

1. Patients received or planned to receive, a non-renal solid organ transplant, a simultaneous pancreas-kidney transplant, or a bone narrow transplant.
2. Patients who already received a kidney transplant (re-transplant).
3. Patients enrolled or planned to be enrolled in any clinical study.
4. Patients suffering from conditions and illnesses that might interfere with the study purpose, according to the investigator's evaluation.

Primary outcomes:
measure: Non aderence
timeFrame: 6 months
Secondary outcomes:
measure: BMQ score
timeFrame: Baseline and 6 months
measure: ACCEPT score
timeFrame: Baseline and 6 months
measure: BAASIS evaluation
timeFrame: Baseline
measure: Patients characteristics
timeFrame: Baseline
measure: Clinical informations as for clinical practice
timeFrame: Baseline and 6 months
measure: Immunosuppressive treatments
timeFrame: Baseline and 6 months
measure: Rejections
timeFrame: Baseline and 6 months
measure: Graft failure
timeFrame: Baseline and 6 months
measure: Adverse events
timeFrame: Baseline and 6 months
measure: Infections
timeFrame: Baseline and 6 months
measure: Healthcare cost
timeFrame: 6 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: A.O.U. Consorziale Policlinico
city: Bologna
country: Italy
facility: A.O.U. Policlinico S.Orsola Malpighi
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: ARNAS Ospedale Civico
city: Pisa
country: Italy
facility: A.O.U. Pisana P.O. Cisanello
city: Pisa
country: Italy
facility: Ospedale Cisanello
city: Roma
country: Italy
facility: Fondazione Policlinico Univ. Gemelli
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza
city: Varese
country: Italy
facility: A.O. Ospedale Circolo e Fondazione Macchi
city: Verona
country: Italy
facility: A.O.U.I. Ospedale Borgo Trento
Study officials:
References: