Liver Disease Clinical Trial
Official title:
CellCept (Mycophenolate Mofetil, MMF) Maintenance Immunosuppression in Liver Transplant Recipients With Long-term Follow-up Post-transplantation for Non-Autoimmune Liver Disease - A Prospective, Randomized, Multicenter Trial.
The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.
Status | Completed |
Enrollment | 19 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female 18 years of age or older (females who can become pregnant must use two acceptable methods of birth control while taking mycophenolate mofetil) - Orthotopic liver transplant more than one year prior to enrollment - Using calcineurin inhibitor to prevent rejection at time of screening - Patients must be willing to provide informed consent and abide by the requirements of the study Exclusion Criteria: - Liver disease may not have been secondary to an autoimmune cause, including: - autoimmune hepatitis, - primary sclerosing cholangitis, - primary biliary cirrhosis - Patients who have had: - more than one prior episode of rejection, - rejection within the past six months, - any corticosteroid resistant rejection - Patients with a tacrolimus trough level of greater than 7 ng/ml within 90 days prior to enrollment - Patients with a cyclosporine trough level greater than 225 ng/ml within 90 days prior to enrollment - Patients taking more the 5 mg per day of prednisone within 90 days prior to enrollment - Patients taking any prednisone within 30 days of enrollment - Allograft dysfunction within 6 months of enrollment, including ALT and/or total bilirubin greater than 2x normal, and/or biopsy proven hepatitis C virus (HCV) with fibrosis greater than stage II - White blood cell count less than 2,500 or platelet count less than 50,000 within 60 days of enrollment - MPA AUC threshold: Patients are not eligible for the study if they do not attain the threshold value MPA AUC (>30 mg*h/L if on CsA, >40 mg*h/L if on tacrolimus) after 50% calcineurin inhibitor reduction, measured using a 3-sample estimate (trough, 30-min, 120-min) - Patients who have had a previous transplant of organ(s) other than liver - Patients who received a liver from a hepatitis C positive donor - Patients who received a liver from a living donor - Patients with any technical complication requiring intervention within the three months prior to screening - Current infection requiring treatment - History of post transplant lymphoproliferative disorder - History of malignancy other than non-melanoma skin cancer or Stage 1-2 hepatoma - Active or unhealed duodenal ulcer - Concomitant treatment with rapamycin and/or interferon - Known allergy or sensitivity to CellCept® or any of its components - Unable or unwilling to comply with the protocol requirements or considered by the investigator(s) to be unfit for the study - Participation in a clinical trial within 30 days prior to study entry or prior enrollment in any CellCept® clinical trial - Pregnant or breastfeeding woman - Diabetes with known, clinically significant gastroparesis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky at Lexington | Lexington | Kentucky |
United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
United States | Texas Transplant Institute | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein Healthcare Network | Hoffmann-La Roche |
United States,
Fraser GM, Grammoustianos K, Reddy J, Rolles K, Davidson B, Burroughs AK. Long-term immunosuppression without corticosteroids after orthotopic liver transplantation: a positive therapeutic aim. Liver Transpl Surg. 1996 Nov;2(6):411-7. — View Citation
Herrero JI, Quiroga J, Sangro B, Girala M, Gómez-Manero N, Pardo F, Alvárez-Cienfuegos J, Prieto J. Conversion of liver transplant recipients on cyclosporine with renal impairment to mycophenolate mofetil. Liver Transpl Surg. 1999 Sep;5(5):414-20. — View Citation
Hodge EE, Reich DJ, Clavien PA, Kim-Schluger L. Use of mycophenolate mofetil in liver transplant recipients experiencing renal dysfunction on cyclosporine or tacrolimus-randomized, prospective, multicenter study results. Transplant Proc. 2002 Aug;34(5):1546-7. — View Citation
Mazariegos GV, Reyes J, Marino IR, Demetris AJ, Flynn B, Irish W, McMichael J, Fung JJ, Starzl TE. Weaning of immunosuppression in liver transplant recipients. Transplantation. 1997 Jan 27;63(2):243-9. — View Citation
McDiarmid SV, Farmer DA, Goldstein LI, Martin P, Vargas J, Tipton JR, Simmons F, Busuttil RW. A randomized prospective trial of steroid withdrawal after liver transplantation. Transplantation. 1995 Dec 27;60(12):1443-50. — View Citation
Munoz SJ, Rothstein KD, Reich D, Manzarbeitia C. Long-term care of the liver transplant recipient. Clin Liver Dis. 2000 Aug;4(3):691-710. Review. — View Citation
Raimondo ML, Dagher L, Papatheodoridis GV, Rolando N, Patch DW, Davidson BR, Rolles K, Burroughs AK. Long-term mycophenolate mofetil monotherapy in combination with calcineurin inhibitors for chronic renal dysfunction after liver transplantation. Transplantation. 2003 Jan 27;75(2):186-90. — View Citation
Reich D, Rothstein K, Manzarbeitia C, Muñoz S. Common medical diseases after liver transplantation. Semin Gastrointest Dis. 1998 Jul;9(3):110-25. Review. — View Citation
Reich DJ, Clavien PA, Hodge EE; MMF Renal Dysfunction after Liver Transplantation Working Group. Mycophenolate mofetil for renal dysfunction in liver transplant recipients on cyclosporine or tacrolimus: randomized, prospective, multicenter pilot study results. Transplantation. 2005 Jul 15;80(1):18-25. — View Citation
Schlitt HJ, Barkmann A, Böker KH, Schmidt HH, Emmanouilidis N, Rosenau J, Bahr MJ, Tusch G, Manns MP, Nashan B, Klempnauer J. Replacement of calcineurin inhibitors with mycophenolate mofetil in liver-transplant patients with renal dysfunction: a randomised controlled study. Lancet. 2001 Feb 24;357(9256):587-91. — View Citation
Shaw LM, Korecka M, Venkataramanan R, Goldberg L, Bloom R, Brayman KL. Mycophenolic acid pharmacodynamics and pharmacokinetics provide a basis for rational monitoring strategies. Am J Transplant. 2003 May;3(5):534-42. Review. — View Citation
Stegall MD, Everson GT, Schroter G, Karrer F, Bilir B, Sternberg T, Shrestha R, Wachs M, Kam I. Prednisone withdrawal late after adult liver transplantation reduces diabetes, hypertension, and hypercholesterolemia without causing graft loss. Hepatology. 1997 Jan;25(1):173-7. — View Citation
Stewart SF, Hudson M, Talbot D, Manas D, Day CP. Mycophenolate mofetil monotherapy in liver transplantation. Lancet. 2001 Feb 24;357(9256):609-10. — View Citation
Wiesner R, Rabkin J, Klintmalm G, McDiarmid S, Langnas A, Punch J, McMaster P, Kalayoglu M, Levy G, Freeman R, Bismuth H, Neuhaus P, Mamelok R, Wang W. A randomized double-blind comparative study of mycophenolate mofetil and azathioprine in combination with cyclosporine and corticosteroids in primary liver transplant recipients. Liver Transpl. 2001 May;7(5):442-50. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Biopsy Proven Rejections at 12 Months | assessed by liver biopsy using Banff International Consensus Schema | 12 months | No |
Secondary | Patient and Graft Survival at 12 Months | 12 months | Yes | |
Secondary | Number of Participants With Adverse Events Including Infections at 12 Months | 12 months | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02798861 -
Controlled Attenuation Parameter (CAP) in Liver Allografts
|
||
Completed |
NCT01968395 -
Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
|
Phase 4 | |
Completed |
NCT01437969 -
Pharmacogenomics Study on IL28B Genetic Variants in Italian Patients With HCV Infection naïve to Treatment.
|
||
Recruiting |
NCT00155376 -
Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography
|
Phase 4 | |
Recruiting |
NCT00172705 -
Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique
|
N/A | |
Completed |
NCT04185454 -
Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese
|
N/A | |
Completed |
NCT02506335 -
Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Heart Disease
|
Early Phase 1 | |
Completed |
NCT02520609 -
Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
|
||
Completed |
NCT02306018 -
Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation
|
N/A | |
Completed |
NCT01970904 -
Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients
|
N/A | |
Completed |
NCT01988753 -
Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
|
||
Terminated |
NCT00741117 -
Conjugated Hyperbilirubinemia and Pulse Oximetry
|
N/A | |
Enrolling by invitation |
NCT01483248 -
Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis
|
Phase 1/Phase 2 | |
Completed |
NCT00074386 -
Kidney and Liver Transplantation in People With HIV
|
N/A | |
Completed |
NCT00245830 -
Ischemic Preconditioning of Liver in Cadaver Donors
|
N/A | |
Completed |
NCT02329821 -
Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection
|
N/A | |
Completed |
NCT01650181 -
Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis
|
Phase 4 | |
Completed |
NCT01303549 -
Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
|
Phase 4 | |
Completed |
NCT00799851 -
A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
|
Phase 4 | |
Completed |
NCT00058890 -
Gabapentin to Treat Itch in Patients With Liver Disease
|
Phase 3 |