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

Kidney Transplant Clinical Trial

Official title:

The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558373
• Other study ID #: DFIDM-1701
• Status: Completed
• Start date: July 31, 2018
• Est. completion date: February 26, 2020

Study information

• Verified date: May 2022
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Drug:
• Immunosuppressive
Immunosuppressive therapies

Locations

Country	Name	City	State
Italy	A.O.U. Consorziale Policlinico	Bari
Italy	A.O.U. Policlinico S.Orsola Malpighi	Bologna
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano
Italy	A.O.U. Maggiore della Carità	Novara
Italy	Azienda Ospedaliera di Padova	Padova
Italy	ARNAS Ospedale Civico	Palermo
Italy	A.O.U. Pisana P.O. Cisanello	Pisa
Italy	Ospedale Cisanello	Pisa
Italy	Fondazione Policlinico Univ. Gemelli	Roma
Italy	A.O.U. Città della Salute e della Scienza	Torino
Italy	A.O. Ospedale Circolo e Fondazione Macchi	Varese
Italy	A.O.U.I. Ospedale Borgo Trento	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non aderence	Proportion of non-adherent patients to immunosuppressive therapy as measured by the Basel Assessment of Adherence with Immunosuppressives Scale (BAASIS©-interview). The BAASIS© consists of four items (with a 6-point scale for responses ranging from never (0) to every day (5)) measuring patients' taking, skipping (or drug holidays), timing (>2 hrs from prescribed time) and dose reduction of drugs. An affirmative answer to any of the first 4 questions results in assignment to the non-adherent group.	6 months
Secondary	BMQ score	Describe the patient's belief about immunosuppresive medicines, as measured by the Belief about Medicines Questionnaire (BMQ). It is an 18-item measure comprising of two subscales (general harm and general overuse), and two subscales (specific necessity and specific concerns). Higher scores in the General-Harm and General-Overuse sub-scales represent an overall negative perception of medication. High scores in the Specific-Concerns sub-scale means that adverse reactions are potentially harmful and high scores in the Specific-Necessity sub-scale are indicative of the patient's need to adhere to medication to maintain health.	Baseline and 6 months
Secondary	ACCEPT score	Describe the patient's acceptance toward immunosuppressive treatment, as measured by the ACCEPT questionnaire. It is a 32-items self-administered questionnaire and covers patient's opinion on: convenience of the medication, length of treatment, constraints due to medication, side effects and a general opinion on the medication. The score ranges from 0 (no acceptance) to 100 (maximum treatment acceptance).	Baseline and 6 months
Secondary	BAASIS evaluation	Perform the BAASIS assessement.The BAASIS consists of four items (with a 6-point scale for responses ranging from never (0) to every day (5)) measuring patients' taking, skipping (or drug holidays), timing (>2 hrs from prescribed time) and dose reduction of drugs. An affirmative answer to any of the first 4 questions results in assignment to the non-adherent group.	Baseline
Secondary	Patients characteristics	Describe patients characteristics (such as socio-demographics, lifestyle information, relevant comorbidities, concomitant medications, clinical characteristics information like e.g. primary kidney disease diagnosis, waiting time before graft, transplant characteristic e.g. type of donor, etc.	Baseline
Secondary	Clinical informations as for clinical practice	Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available)	Baseline and 6 months
Secondary	Immunosuppressive treatments	Immunosuppressive treatments description and changes	Baseline and 6 months
Secondary	Rejections	Occurrence of rejection episodes	Baseline and 6 months
Secondary	Graft failure	Occurrence of graf failure	Baseline and 6 months
Secondary	Adverse events	Number of adverse events	Baseline and 6 months
Secondary	Infections	Occurrence of infections	Baseline and 6 months
Secondary	Healthcare cost	Assess the healthcare cost (ER admission, hospitalizations)	6 months