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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
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The primary objective of this study is to evaluate the efficacy of 6-month treatment with Advagraf® converted from 12-month treatment with tacrolimus in stable liver transplant recipients.
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.
This is single-center, single-group, open-label study, phase 4 IIT. The Subject is transplantated liver at a minimum of 12 month of screening and at least 12 month Treatment with a Tacrolimus stably And start screening after obtain consent to participate in clinical trials, if appropriate in the selection criteria do not apply to the exclusion criteria are enrolled in clinical trials.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tacrolimus | Experimental | conversion to Advagraf |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advagraf | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute rejection confirmed by biopsy in 24 weeks after conversion |
| within 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of acute rejection confirmed by biopsy in 24 weeks after conversion | * For the subjects who developed acute rejection at least once, severity of acute rejection is defined as the highest severity. | within 24 weeks |
| Incidence of chronic rejection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ki Won Song, doctral | Asan Medical Center, Hepatobiliary, Liver Transplantion Surgery center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Asan Medical Center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11003346 | Result | 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. | |
| 11072057 | Result | 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. |
| Label | URL |
|---|---|
| test link(2000 Sep 15;70(5):711-6.) | View source |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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|
|
* Chronic rejection will be confirmed by biopsy. |
| within 24 weeks |
| Patient and graft survival rates in 24 weeks after conversion | within 24 weeks |
| Time from conversion to onset of acute rejection | within 24 weeks |
| Tacrolimus trough level at each visit | within 24 weeks |
| Incidence of adverse events | within 24 weeks |
| Tacrolimus compliance | Evaluation of adherence through a subject questionnaire | within 24 weeks |
| 2305467 | Result | 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. |
| 10071354 | Result | 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. |
| 21958123 | Result | 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. |
| 20840481 | Result | 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. |
| 20534291 | Result | 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. |
| 20534292 | Result | 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. |
| 19715867 | Result | 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. |
| 26256081 | Result | 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. |
| test link(2000 Nov-Dec;22(6):412-24.) | View source |
| test link(1990 Feb;49(2):374-7.) | View source |
| test link(1999 Mar;5(2):144-50.) | View source |
| test link(2012 Jan-Feb;26(1):E32-7. doi: 10.1111/j.1399-0012.2011.01521.x. Epub 2011 Sep 30.) | View source |
| test link(2010 Oct;10(10):2313-23. doi: 10.1111/j.1600-6143.2010.03255.x. Epub 2010 Sep 14.) | View source |
| test link( 2010 May;42(4):1320-1. doi: 10.1016/j.transproceed.2010.03.106.) | View source |
| test link(2010 May;42(4):1322-4. doi: 10.1016/j.transproceed.2010.04.012.) | View source |
| test link(2009 Jul-Aug;41(6):2184-6. doi: 10.1016/j.transproceed.2009.06.085.) | View source |
| test link(2015 Aug;14(4):374-9.) | View source |