Adherence to Medication RegimePhase 4NCT02251691
Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant
A Phase 4 study testing Advagraf and Prograf in people with Adherence to Medication Regime, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The main objective of this study was to compare the drug compliance in patients after renal transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen. The rationale for this study is to access the influence of once-daily prolonged-release tacrolimus versus standard twice-daily tacrolimus on… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Adherence to Medication Regime
- What is being tested?
- Advagraf and Prograf
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 May 2014to 31 Mar 2020
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients at 20-65 years of age undergoing renal transplantation
- Patients who have been informed of the potential risks and side effects of the study
- Female patients of childbearing potential must agree to maintain effective birth control during the study.
- Patients have been fully informed and have given written informed consent to participate in the study
Who cannot join
- Donor age greater than 65 years
- Patients receiving a perfectly matched kidney (6 matches HLA-A, B, DR)
- Patients who are recipients of multiple solid organ transplants
- Patients undergoing second or subsequent transplantation
- Patients with pre-transplant PRA > 20%
- Patients with ABO incompatibility or positive lymphocytotoxicity
Show all 15Show fewer
- Patients with severe, active infection
- Patients who have an abnormal liver profile such as ALT, AST, alkaline phosphatase or total bilirubin >3 times the upper normal limit
- Patient who are HIV-positive or hepatitis C (PCR+ only) B surface antigen positive
- Patients who have been treated with an investigational drug or therapy within one month prior to entry or who will be so treated within 6 months of transplantation
- Patients with a history of malignancy within the last five years except excised squamous or basal cell carcinoma
- Patients with a history of alcohol or drug abuse or signs of alcohol-induced organ damage, mental dysfunction or other factors limiting their ability to comply fully with the study requirements.
- Patients who require on-going dosing with a systemic immunosuppressive drugs prior to transplantation.
- Pregnant woman or breast-feeding mother during the period of this study.
- Patients who are allergy to tacrolimus, macrolide antibiotics, steroid or mycophenolate mofetil.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chin-Yuan Lee, +886-972651446, gs2119@gmail.com
About this study
Official title: The Influence of Once-daily Versus Twice-daily Immunosuppressive Regimen on Drug Compliance in Patients After Renal Transplantation
The main objective of this study was to compare the drug compliance in patients after renal transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.
The rationale for this study is to access the influence of once-daily prolonged-release tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation recipients base on the assumption that once-daily dosing regimen may help to improve drug compliance.
Read the detailed description
This study will be a prospective, two-arm randomized and open-label, phase IV study to compare the drug compliance in patients under prolonged-release once-daily tacrolimus versus standard twice-daily tacrolimus based regimen after de novo renal transplantation.
The investigators will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)
- Conditions
- Adherence to Medication Regime
- Being tested
- Advagraf, Prograf
- Keywords
- Compliance
- Medical subject headings
- Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvagrafDrug
Also called Advagraf once daily
Compare the drug compliance between once daily or twice daily regimen
PrografDrug
Also called Prograf twice daily
Compare the drug compliance between once daily or twice daily regimen
| Study group | Role | What they receive |
|---|---|---|
| Advagraf | Experimental | Take Advagraf once daily Receives: Drug: Advagraf |
| Prograf | Active comparator | Take tacrolimus twice daily Receives: Drug: Prograf |
What is being measured
The primary outcome is the main question the study is designed to answer.
basal assessment of adherence with immunosuppressive medication scale
We will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)
Measured: 12 months
Secondary outcomes (3)
serum creatinine level
We will evaluate the serum creatinine level of the patients enrolled in this study.
Measured: 12 months
graft survival
We will evaluate the graft survival of the patients enrolled in this study.
Measured: 12 months
patient survival
We will evaluate the patient survival of the patients enrolled in this study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start9 May 2014
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adherence to Medication RegimeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Responsible party
- Sponsor
- Investigators
- Chin-Yuan Lee, Principal investigator, hospital medical school affiliations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251691
- Sponsor's protocol ID
- 201401105MIPA
- Status last verified
- Mar 2019
- First submitted
- 15 Jun 2014
- Last updated
- 2 Apr 2019
- 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 36094829
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Once-daily Versus Twice-daily Immunosuppressive Regimen on Drug Compliance in Patients After Renal Transplantation
- ClinicalTrials.gov ID
- NCT02251691
- Acronym / sponsor ID
- 201401105MIPA
- Conditions
- Adherence to Medication Regime
- Keywords
- Compliance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Astellas Pharma Taiwan, Inc.
- Study start
- 9 May 2014 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 29 Sep 2014 (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.
The main objective of this study was to compare the drug compliance in patients after renal transplantation under once or twice-daily tacrolimus-based immunosuppressive regimen.
The rationale for this study is to access the influence of once-daily prolonged-release tacrolimus versus standard twice-daily tacrolimus on drug compliance in renal transplantation recipients base on the assumption that once-daily dosing regimen may help to improve drug compliance.
Detailed description
This study will be a prospective, two-arm randomized and open-label, phase IV study to compare the drug compliance in patients under prolonged-release once-daily tacrolimus versus standard twice-daily tacrolimus based regimen after de novo renal transplantation.
The investigators will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advagraf | Experimental | Drug: AdvagrafTake Advagraf once daily |
| Prograf | Active comparator | Drug: PrografTake tacrolimus twice daily |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients at 20-65 years of age undergoing renal transplantation
- Patients who have been informed of the potential risks and side effects of the study
- Female patients of childbearing potential must agree to maintain effective birth control during the study.
- Patients have been fully informed and have given written informed consent to participate in the study
Key exclusion criteria (15 listed)
- Donor age greater than 65 years
- Patients receiving a perfectly matched kidney (6 matches HLA-A, B, DR)
- Patients who are recipients of multiple solid organ transplants
- Patients undergoing second or subsequent transplantation
- Patients with pre-transplant PRA > 20%
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 |
|---|---|---|
| AdvagrafAlso: Advagraf once dailyCompare the drug compliance between once daily or twice daily regimen | Drug | Advagraf |
| PrografAlso: Prograf twice dailyCompare the drug compliance between once daily or twice daily regimen | Drug | Prograf |
Primary outcome
basal assessment of adherence with immunosuppressive medication scale
Time frame: 12 months
We will evaluate the drug compliance of the patients under once or twice-daily tacrolimus-based regimen using the medication scale BAAIS® (basal assessment of adherence with immunosuppressive medication scale)
3 secondary outcomes
serum creatinine level
Time frame: 12 months
graft survival
Time frame: 12 months
patient survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- 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.
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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.
Chin-Yuan Lee principal investigator
hospital medical school affiliations
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 Advagraf and Prograf in people with Adherence to Medication Regime, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Apr 2019. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chin-Yuan Lee (+886-972651446, gs2119@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
basal assessment of adherence with immunosuppressive medication scale (time frame: 12 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 NCT02251691, which also lists 1 linked publication.
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 2 Apr 2019.