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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
101 participants
INTERVENTIONAL
2016-11-30
2020-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The secondary objective of this study is to evaluate severity of acute rejection confirmed by biopsy in 24 weeks, incidence of chronic rejection, patient and graft survival rates in 24 weeks, incidence of adverse events, blood pressure, tacrolimus trough level, drug compliance, and adherence.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
NCT04761731
To Evaluate the Efficacy and Safety of ADVAGRAF® After Treatment With a Tacrolimus in New Liver Transplant Recipients
NCT03423225
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation
NCT01339468
A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjects
NCT01882322
Efficacy and Safety Study of a 4-Month Post-Renal Transplant Dose Reduction of Tacrolimus(ADEQUATE)
NCT01744470
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Administration method is following : The total daily dose of -1 tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning for 24 weeks, starting from Day 0.
Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment.
Duration of treatment : The investigational product will be administered for 24 weeks.
Tacrorimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before have of Investigational Product)
Subjects, who participated in this clinical trial, are scheduled up to 5 times, and it will be proceed for 24 weeks. (screening and baseline, 3 weeks, 12 weeks, 24 weeks) admitted for 24 weeks including a screening visit.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
tacrolimus
conversion to Advagraf
Advagraf
Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment. Duration of treatment The investigational product will be administered for 24 weeks. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before administrated of Investigational Product)
Tacrolimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy.
( ① -1day to enrollment : swich to the day before ADVAGRAF®, ② 0day to enrollment : the day swich to ADVAGRAF® )
Duration of treatment the investigational product will be administered for 24 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Advagraf
Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5\~10ng/ml of study treatment. Duration of treatment The investigational product will be administered for 24 weeks. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before administrated of Investigational Product)
Tacrolimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy.
( ① -1day to enrollment : swich to the day before ADVAGRAF®, ② 0day to enrollment : the day swich to ADVAGRAF® )
Duration of treatment the investigational product will be administered for 24 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Those who were transplantated liver at a minimum of 12 month of screening and after 12 month Treatment with a Tacrolimus stably.(Brain dead transplantation or biological transplant no values)
3. tacrolimus blood everage level is 3-10 ng/ml for at least 6 months prior to screening.
4. Female subjects of child bearing potential must have a negative urine or serum pregnancy test prior to enrollment and at the end of study and must agree to practice effective birth control during the study.
5. Subjects are stable clinically in the opinion of the investigator.
6. Subjects capable of understanding the purpose and risks of the study, having been fully informed and has given written informed consent to participate in the study
Exclusion Criteria
2. Acute rejection confirmed by histologic response or the patient had chronic rejection
3. Subjects diagnosed new malignant tumor before the pre-screening within five years , with the exception of basalioma or squamous cell carcinoma or carcinoma in situ of the skin that has been treated successfully.
4. Subjects allergic to tacrolimus or investigational product.
5. Subjects are unstable clinically state in the opinion of the investigator.
6. Subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator.
7. Subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days.
8. Subjects taking forbidden concomitant medications or within 28 days prior to enroll.
9. Subjects who are pregnant or breast-feeding mother.
10. Subjects unlikely to comply with the visits scheduled in the protocol.
11. Subjects with renal dysfunction on the investigator's point of view or serum creatinine \> 1.6mg/dL or GFR(MDRD)\<30mL/min in the baseline.
12. Hepatic dysfunction: rising more than double the normal range of SGPT/ALT and/or SGOT/AST and/or bilirubin, hepatic cirrhosis
19 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asan Medical Center
OTHER
Linical Korea
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ki Won Song, doctral
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center, Hepatobiliary, Liver Transplantion Surgery center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul Asan Medical Center
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bunzel B, Laederach-Hofmann K. Solid organ transplantation: are there predictors for posttransplant noncompliance? A literature overview. Transplantation. 2000 Sep 15;70(5):711-6. doi: 10.1097/00007890-200009150-00001.
Laederach-Hofmann K, Bunzel B. Noncompliance in organ transplant recipients: a literature review. Gen Hosp Psychiatry. 2000 Nov-Dec;22(6):412-24. doi: 10.1016/s0163-8343(00)00098-0.
Schweizer RT, Rovelli M, Palmeri D, Vossler E, Hull D, Bartus S. Noncompliance in organ transplant recipients. Transplantation. 1990 Feb;49(2):374-7. doi: 10.1097/00007890-199002000-00029.
Jain AB, Kashyap R, Rakela J, Starzl TE, Fung JJ. Primary adult liver transplantation under tacrolimus: more than 90 months actual follow-up survival and adverse events. Liver Transpl Surg. 1999 Mar;5(2):144-50. doi: 10.1002/lt.500050209.
Dopazo C, Rodriguez R, Llado L, Calatayud D, Castells L, Ramos E, Molina V, Garcia R, Fabregat J, Charco R. Successful conversion from twice-daily to once-daily tacrolimus in liver transplantation: observational multicenter study. Clin Transplant. 2012 Jan-Feb;26(1):E32-7. doi: 10.1111/j.1399-0012.2011.01521.x. Epub 2011 Sep 30.
Trunecka P, Boillot O, Seehofer D, Pinna AD, Fischer L, Ericzon BG, Troisi RI, Baccarani U, Ortiz de Urbina J, Wall W; Tacrolimus Prolonged Release Liver Study Group. Once-daily prolonged-release tacrolimus (ADVAGRAF) versus twice-daily tacrolimus (PROGRAF) in liver transplantation. Am J Transplant. 2010 Oct;10(10):2313-23. doi: 10.1111/j.1600-6143.2010.03255.x. Epub 2010 Sep 14.
Comuzzi C, Lorenzin D, Rossetto A, Faraci MG, Nicolini D, Garelli P, Bresadola V, Toniutto P, Soardo G, Baroni GS, Adani GL, Risaliti A, Baccarani U. Safety of conversion from twice-daily tacrolimus (Prograf) to once-daily prolonged-release tacrolimus (Advagraf) in stable liver transplant recipients. Transplant Proc. 2010 May;42(4):1320-1. doi: 10.1016/j.transproceed.2010.03.106.
Merli M, Di Menna S, Giusto M, Giannelli V, Lucidi C, Loria I, Ginanni Corradini S, Mennini G, Rossi M. Conversion from twice-daily to once-daily tacrolimus administration in liver transplant patient. Transplant Proc. 2010 May;42(4):1322-4. doi: 10.1016/j.transproceed.2010.04.012.
Marin-Gomez LM, Gomez-Bravo MA, Alamo-Martinez JA, Barrera-Pulido L, Bernal Bellido C, Suarez Artacho G, Pascasio JM. Evaluation of clinical safety of conversion to Advagraf therapy in liver transplant recipients: observational study. Transplant Proc. 2009 Jul-Aug;41(6):2184-6. doi: 10.1016/j.transproceed.2009.06.085.
Kim SH, Lee SD, Kim YK, Park SJ. Conversion of twice-daily to once-daily tacrolimus is safe in stable adult living donor liver transplant recipients. Hepatobiliary Pancreat Dis Int. 2015 Aug;14(4):374-9. doi: 10.1016/s1499-3872(15)60378-2.
Related Links
Access external resources that provide additional context or updates about the study.
test link(2000 Sep 15;70(5):711-6.)
test link(2000 Nov-Dec;22(6):412-24.)
test link(1990 Feb;49(2):374-7.)
test link(1999 Mar;5(2):144-50.)
test link(2012 Jan-Feb;26(1):E32-7. doi: 10.1111/j.1399-0012.2011.01521.x. Epub 2011 Sep 30.)
test link(2010 Oct;10(10):2313-23. doi: 10.1111/j.1600-6143.2010.03255.x. Epub 2010 Sep 14.)
test link( 2010 May;42(4):1320-1. doi: 10.1016/j.transproceed.2010.03.106.)
test link(2010 May;42(4):1322-4. doi: 10.1016/j.transproceed.2010.04.012.)
test link(2009 Jul-Aug;41(6):2184-6. doi: 10.1016/j.transproceed.2009.06.085.)
test link(2015 Aug;14(4):374-9.)
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STABLE
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.