Influence of Once-daily Versus Twice-daily Immunosuppressant on Renal Transplant
NCT ID: NCT02251691
Last Updated: 2019-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
90 participants
INTERVENTIONAL
2014-05-09
2020-03-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Advagraf
Take Advagraf once daily
Advagraf
Compare the drug compliance between once daily or twice daily regimen
Prograf
Take tacrolimus twice daily
Prograf
Compare the drug compliance between once daily or twice daily regimen
Interventions
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Advagraf
Compare the drug compliance between once daily or twice daily regimen
Prograf
Compare the drug compliance between once daily or twice daily regimen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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.
20 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Taiwan, Inc.
INDUSTRY
National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chin-Yuan Lee
Role: PRINCIPAL_INVESTIGATOR
hospital medical school affiliations
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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201401105MIPA
Identifier Type: -
Identifier Source: org_study_id
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