Kidney TransplantNCT03558373
The Adherence of Immunosuppressive Therapy Including Tacrolimus Once-daily in Italian Kidney Transplant Recipients
An observational study of Kidney Transplant, run by Chiesi Farmaceutici S.p.A. at 12 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Immunosuppressive
- How many people
- 158 participants
- Where
- 12 sitesItaly
- Study dates
- 31 Jul 2018to 26 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplant recipients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites
A.O.U. Consorziale Policlinico
Bari
A.O.U. Policlinico S.Orsola Malpighi
Bologna
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
A.O.U. Maggiore della Carità
Novara
Azienda Ospedaliera di Padova
Padova
ARNAS Ospedale Civico
Palermo
A.O.U. Pisana P.O. Cisanello
Pisa
Ospedale Cisanello
Pisa
Fondazione Policlinico Univ. Gemelli
Roma
A.O.U. Città della Salute e della Scienza
Torino
A.O. Ospedale Circolo e Fondazione Macchi
Varese
A.O.U.I. Ospedale Borgo Trento
Verona
About this study
Official title: The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study
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.).
- Conditions
- Kidney Transplant
- Being tested
- Immunosuppressive
- Keywords
- adherence, tacrolimus, once-daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunosuppressiveDrug
Immunosuppressive therapies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (11)
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.
Measured: Baseline and 6 months
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).
Measured: Baseline and 6 months
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.
Measured: Baseline
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.
Measured: Baseline
Clinical informations as for clinical practice
Collect clinical information (e.g. routine tacrolimus trough levels, eGFR if available)
Measured: Baseline and 6 months
Immunosuppressive treatments
Immunosuppressive treatments description and changes
Measured: Baseline and 6 months
Rejections
Occurrence of rejection episodes
Measured: Baseline and 6 months
Graft failure
Occurrence of graf failure
Measured: Baseline and 6 months
Adverse events
Number of adverse events
Measured: Baseline and 6 months
Infections
Occurrence of infections
Measured: Baseline and 6 months
Healthcare cost
Assess the healthcare cost (ER admission, hospitalizations)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start31 Jul 2018
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558373
- Sponsor's protocol ID
- DFIDM-1701
- Status last verified
- May 2022
- First submitted
- 28 May 2018
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adherence of Immunosuppressive Therapy Including Tacrolimus Once Daily in a Cohort of Kidney Transplant Recipients: an Italian Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03558373
- Acronym / sponsor ID
- DFIDM-1701
- Conditions
- Kidney Transplant
- Keywords
- adherence, tacrolimus, once-daily
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplant recipients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunosuppressiveImmunosuppressive therapies | Drug | – |
Primary outcome
Non aderence
Time frame: 6 months
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.
11 secondary outcomes
BMQ score
Time frame: Baseline and 6 months
ACCEPT score
Time frame: Baseline and 6 months
BAASIS evaluation
Time frame: Baseline
Patients characteristics
Time frame: Baseline
Clinical informations as for clinical practice
Time frame: Baseline and 6 months
Immunosuppressive treatments
Time frame: Baseline and 6 months
Rejections
Time frame: Baseline and 6 months
Graft failure
Time frame: Baseline and 6 months
Adverse events
Time frame: Baseline and 6 months
Infections
Time frame: Baseline and 6 months
Healthcare cost
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant, run by Chiesi Farmaceutici S.p.A. at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non aderence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.