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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is to gather information regarding the use of Myfortic, Prograf, and corticosteroids in new liver transplant recipients. These three medicines help to prevent the body from rejecting the transplanted liver. The information the investigators are obtaining is data relating to the process of Myfortic absorption by the body, its distribution in the body, the breakdown of Myfortic in the body, and its elimination from the body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.
Myfortic is approved for use in kidney transplant recipients, and has been prescribed by doctors for liver transplant recipients. No study has been reported to date evaluating the pharmacokinetics of Myfortic in new liver transplant recipients who also take Prograf and corticosteroids. During this six month study, a series of blood samples will be obtained after subjects take Myfortic, Prograf, and corticosteroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | de novo liver transplant recipients receiving Enteric-coated Mycophenolate Sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enteric-coated Mycophenolate Sodium | Drug | 1440mg/day for 6 months posttransplant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | Pharmacokinetic time points will be obtained at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, and 12 hours post dose. The exposure (area under the concentration-time curve, AUC μg·h/mL, Cmax ng/mL, and Tmax, hours) of MPA and MPAG will be calculated using non-compartmental analysis. | Twelve hour pharmacokinetics at one week, one month, and six months post transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | MPA exposure will be assessed at one week, 1 month, and 6 months. Kidney function (using MDRD and Cockcroft-Gault) will be compared with PK parameters and graft survival recorded. Adverse events will be recorded. | 1 week, 1 month, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with end stage liver disease who are receiving a liver transplant at The Methodist Hospital in Houston, Texas and who satify the inclusion/exclusion criteria will be considered for the study.
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| Name | Affiliation | Role |
|---|---|---|
| R M Ghobrial, MD, PhD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Methodist Hospital System | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11505071 | Background | Plank LD, Metzger DJ, McCall JL, Barclay KL, Gane EJ, Streat SJ, Munn SR, Hill GL. Sequential changes in the metabolic response to orthotopic liver transplantation during the first year after surgery. Ann Surg. 2001 Aug;234(2):245-55. doi: 10.1097/00000658-200108000-00015. | |
| 19929929 | Background | de Carvalho L, Parise ER, Samuel D. Factors associated with nutritional status in liver transplant patients who survived the first year after transplantation. J Gastroenterol Hepatol. 2010 Feb;25(2):391-6. doi: 10.1111/j.1440-1746.2009.06033.x. Epub 2009 Nov 19. |
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Plan to share data to be determined.
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| ID | Term |
|---|---|
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Serum will be retained and frozen for MPA levels
| 15601803 | Background | Pisupati J, Jain A, Burckart G, Hamad I, Zuckerman S, Fung J, Venkataramanan R. Intraindividual and interindividual variations in the pharmacokinetics of mycophenolic acid in liver transplant patients. J Clin Pharmacol. 2005 Jan;45(1):34-41. doi: 10.1177/0091270004270145. |
| 11269567 | Background | Jain A, Venkataramanan R, Hamad IS, Zuckerman S, Zhang S, Lever J, Warty VS, Fung JJ. Pharmacokinetics of mycophenolic acid after mycophenolate mofetil administration in liver transplant patients treated with tacrolimus. J Clin Pharmacol. 2001 Mar;41(3):268-76. doi: 10.1177/00912700122010087. |
| 15740555 | Background | Arns W, Breuer S, Choudhury S, Taccard G, Lee J, Binder V, Roettele J, Schmouder R. Enteric-coated mycophenolate sodium delivers bioequivalent MPA exposure compared with mycophenolate mofetil. Clin Transplant. 2005 Apr;19(2):199-206. doi: 10.1111/j.1399-0012.2004.00318.x. |
| 17488394 | Background | Perry TW, Christians U, Trotter JF, Bendrick-Peart J. Pharmacokinetics of enteric-coated mycophenolate sodium in stable liver transplant recipients. Clin Transplant. 2007 May-Jun;21(3):413-6. doi: 10.1111/j.1399-0012.2007.00662.x. |
| 18641552 | Background | Kaczmarek I, Bigdeli AK, Vogeser M, Mueller T, Beiras-Fernandez A, Kaczmarek P, Schmoeckel M, Meiser B, Reichart B, Ueberfuhr P. Defining algorithms for efficient therapeutic drug monitoring of mycophenolate mofetil in heart transplant recipients. Ther Drug Monit. 2008 Aug;30(4):419-27. doi: 10.1097/FTD.0b013e31817d7064. |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |