Renal DiseasePhase 4NCT01334333
Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients
A Phase 4 study testing Tacrolimus - Prograf® twice daily formulation and Tacrolimus - Advagraf® once daily formulation in people with Renal Disease and Renal Transplant, run by University of British Columbia at 1 site in Canada.
Trial summary
A critical aspect of real-world functioning following kidney transplantation involves how adherent individuals are to their medication regimens. Regardless of the possible dangers of failing to adhere to anti-rejection medications, such as increased graft rejection, studies have reported rates of non-adherence at… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Renal Disease, Renal Transplant
- What is being tested?
- Tacrolimus - Prograf® twice daily formulation and Tacrolimus - Advagraf® once daily formulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2011to 1 Mar 2018
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a minimum of one year post renal transplant with a successful kidney graft and stable renal function (estimated glomerular filtration rate [GFR (glomerular filtration rate)] above 25 ml/minute per 1.73 m2).
- currently prescribed tacrolimus
- able to swallow pills
- a minimum of grade six education
- fluent in the English language.
Who cannot join
- refusal to or inability to give written informed consent.
- any visual, hearing or other sensory/motor impairments which may interfere with the testing procedures.
- have had a stroke determined to be of significant severity
- have had a head injury determined to be of significant severity
- have a current psychiatric diagnosis determined to be of significant severity
- have the presence of an acute illness (e.g., metastatic cancer), neurological disease, and other major organ failure (e.g., end stage liver disease)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Solid Organ Transplant Clinic, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Comparison of Medication Adherence Between Once Daily Tacrolimus (Advagraf®) and Twice Daily Tacrolimus (Prograf®) Administration in Stable Renal Transplant Recipients - a Randomized Study
A critical aspect of real-world functioning following kidney transplantation involves how adherent individuals are to their medication regimens. Regardless of the possible dangers of failing to adhere to anti-rejection medications, such as increased graft rejection, studies have reported rates of non-adherence at almost 50% following renal transplant.
The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser University, has previously identified relationships between several potentially important cognitive and psychosocial variables, and self-reported medication adherence in renal transplant recipients, including depressive symptoms, as well as everyday and traditional cognitive functioning [4]. The possibility that changes in dosing regimens for a given medication may have an additional impact on medication adherence presents an important issue worth further exploration.
Read more
The current study will allow for more thorough delineation of the roles of psychosocial and cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition, the investigators will assess whether different dosing formulations of tacrolimus impact adherence behaviors in renal transplant recipients.
The proposed research has two primary aims to examine:
- To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients.
- To examine whether different formulations of tacrolimus (once per day dosing versus twice per day dosing) will impact medication adherence in renal transplant recipients.
- Conditions
- Renal Disease, Renal Transplant
- Being tested
- Tacrolimus - Prograf® twice daily formulation, Tacrolimus - Advagraf® once daily formulation
- Keywords
- kidney transplant, tacrolimus, medication adherence, depression, neuropsychological, cognition, Self-efficacy, everyday problem solving
- Medical subject headings
- Kidney Diseases, Medication Adherence, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus - Prograf® twice daily formulationDrug
Also called Prograf®
twice daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant
Tacrolimus - Advagraf® once daily formulationDrug
Also called Advagraf®
once daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant
| Study group | Role | What they receive |
|---|---|---|
| Prograf® | Active comparator | Prograf® is a twice daily formulation of tacrolimus Receives: Drug: Tacrolimus - Prograf® twice daily formulation |
| Advagraf® | Experimental | Advagraf® is a once daily formulation of tacrolimus Receives: Drug: Tacrolimus - Advagraf® once daily formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
electronic monitor of medication taking
electronic bottle tops will be used to monitor medication adherence using MEMS (medication event monitoring system) Caps technology for a period of 4 months.
Measured: 4 months
Secondary outcomes (3)
blood levels of medication
blood levels of tacrolimus will be monitored throughout the study.
Measured: 4 months
self-reported medication adherence
self-report medication adherence questionnaires will also be used to assess medication adherence.
Measured: 4 months
pharmacy refill data
pharmacy refill data from the hospital pharmacy where all participants receive their medications will also be examined to determine medication adherence.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study start11 Nov 2011
- Primary completion30 Oct 2014
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Simon Fraser University, Astellas Pharma Canada, Inc.
- Responsible party
- Sponsor
- Investigators
- R. Jean Shapiro, M.D., Principal investigator, University of British ColumbiaWendy Loken Thornton, Ph.D., Principal investigator, Simon Fraser UniversityNilufar Partovi, Pharm.D., Principal investigator, University of British ColumbiaTheone SE Paterson, M.A., Principal investigator, Simon Fraser University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334333
- Sponsor's protocol ID
- H11-00446
- Status last verified
- May 2018
- First submitted
- 11 Apr 2011
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829Paterson TSE, Demian M, Shapiro RJ, Loken Thornton W. Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Aug 17;6:2054358119867993. doi: 10.1177/2054358119867993. eCollection 2019.
PubMed 31452902
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Medication Adherence Between Once Daily Tacrolimus (Advagraf®) and Twice Daily Tacrolimus (Prograf®) Administration in Stable Renal Transplant Recipients - a Randomized Study
- ClinicalTrials.gov ID
- NCT01334333
- Acronym / sponsor ID
- H11-00446
- Conditions
- Renal Disease, Renal Transplant
- Keywords
- kidney transplant, tacrolimus, medication adherence, depression, neuropsychological, cognition, Self-efficacy, everyday problem solving
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Simon Fraser University, Astellas Pharma Canada, Inc.
- Study start
- 11 Nov 2011 (actual)
- Primary completion
- 30 Oct 2014 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 13 Apr 2011 (estimated)
- 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.
A critical aspect of real-world functioning following kidney transplantation involves how adherent individuals are to their medication regimens. Regardless of the possible dangers of failing to adhere to anti-rejection medications, such as increased graft rejection, studies have reported rates of non-adherence at almost 50% following renal transplant.
The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser University, has previously identified relationships between several potentially important cognitive and psychosocial variables, and self-reported medication adherence in renal transplant recipients, including depressive symptoms, as well as everyday and traditional cognitive functioning [4]. The possibility that changes in dosing regimens for a given medication may have an additional impact on medication adherence presents an important issue worth further exploration.
The current study will allow for more thorough delineation of the roles of psychosocial and cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition, the investigators will assess whether different dosing formulations of tacrolimus impact adherence behaviors in renal transplant recipients.
The proposed research has two primary aims to examine:
- To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients.
- To examine whether different formulations of tacrolimus (once per day dosing versus twice per day dosing) will impact medication adherence in renal transplant recipients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prograf® | Active comparator | Drug: Tacrolimus - Prograf® twice daily formulationPrograf® is a twice daily formulation of tacrolimus |
| Advagraf® | Experimental | Drug: Tacrolimus - Advagraf® once daily formulationAdvagraf® is a once daily formulation of tacrolimus |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a minimum of one year post renal transplant with a successful kidney graft and stable renal function (estimated glomerular filtration rate [GFR (glomerular filtration rate)] above 25 ml/minute per 1.73 m2).
- currently prescribed tacrolimus
- able to swallow pills
- a minimum of grade six education
- fluent in the English language.
Key exclusion criteria (6 listed)
- refusal to or inability to give written informed consent.
- any visual, hearing or other sensory/motor impairments which may interfere with the testing procedures.
- have had a stroke determined to be of significant severity
- have had a head injury determined to be of significant severity
- have a current psychiatric diagnosis determined to be of significant severity
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 |
|---|---|---|
| Tacrolimus - Prograf® twice daily formulationAlso: Prograf®twice daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant | Drug | Prograf® |
| Tacrolimus - Advagraf® once daily formulationAlso: Advagraf®once daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant | Drug | Advagraf® |
Primary outcome
electronic monitor of medication taking
Time frame: 4 months
electronic bottle tops will be used to monitor medication adherence using MEMS (medication event monitoring system) Caps technology for a period of 4 months.
3 secondary outcomes
blood levels of medication
Time frame: 4 months
self-reported medication adherence
Time frame: 4 months
pharmacy refill data
Time frame: 4 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 17 May 2018.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
- Derived from this study: PubMed 31452902Paterson TSE, Demian M, Shapiro RJ, Loken Thornton W. Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Aug 17;6:2054358119867993. doi: 10.1177/2054358119867993. eCollection 2019.
Related trials for Renal Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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.
R. Jean Shapiro, M.D. principal investigator
University of British Columbia
Wendy Loken Thornton, Ph.D. principal investigator
Simon Fraser University
Nilufar Partovi, Pharm.D. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus - Prograf® twice daily formulation and Tacrolimus - Advagraf® once daily formulation in people with Renal Disease and Renal Transplant, run by University of British Columbia at 1 site in Canada.
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 6 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 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
electronic monitor of medication taking (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334333, which also lists 2 linked publications.
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 17 May 2018.