NCT03558373

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.).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2020

Completed
Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

May 28, 2018

Last Update Submit

May 4, 2022

Conditions

Kidney Transplant

Keywords

adherencetacrolimusonce-daily

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • BMQ score

    Baseline and 6 months

  • ACCEPT score

    Baseline and 6 months

  • BAASIS evaluation

    Baseline

  • Patients characteristics

    Baseline

  • Clinical informations as for clinical practice

    Baseline and 6 months

  • +6 more secondary outcomes

Interventions

ImmunosuppressiveDRUG

Immunosuppressive therapies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Kidney transplant recipients

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

A.O.U. Consorziale Policlinico

Bari, Italy

Location

A.O.U. Policlinico S.Orsola Malpighi

Bologna, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

A.O.U. Maggiore della Carità

Novara, Italy

Location

Azienda Ospedaliera di Padova

Padua, Italy

Location

ARNAS Ospedale Civico

Palermo, Italy

Location

A.O.U. Pisana P.O. Cisanello

Pisa, Italy

Location

Ospedale Cisanello

Pisa, Italy

Location

Fondazione Policlinico Univ. Gemelli

Roma, Italy

Location

A.O.U. Città della Salute e della Scienza

Torino, Italy

Location

A.O. Ospedale Circolo e Fondazione Macchi

Varese, Italy

Location

A.O.U.I. Ospedale Borgo Trento

Verona, Italy

Location

MeSH Terms

Interventions

Immunosuppressive Agents

Intervention Hierarchy (Ancestors)

Immunologic FactorsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 15, 2018

Study Start

July 31, 2018

Primary Completion

February 26, 2020

Study Completion

February 26, 2020

Last Updated

May 5, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(12)