Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
NCT ID: NCT01936519
Last Updated: 2021-01-29
Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2013-12-16
Study Completion Date
2019-07-31
Brief Summary
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This study will examine the renal sparing impact of implementing a strategy of conversion to everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post liver transplant
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Detailed Description
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Given the increasing proportion of patients having renal failure at the time of transplant, with the nephrotoxic effect of calcineurin inhibitor based immunosuppression associated with its long term negative survival impact, this study proposes to examine the renal sparing impact of conversion to everolimus from a calcineurin inhibitor based immunosuppressive protocol at 3 months post liver transplant. The 3 month time point was chosen to allow for the switch to everolimus to occur at a period of stable post transplant liver function when both technical and rejection risks are lower. The 3 month cut off was also chosen because of data indicating that worsening renal function at 4 weeks, 3 months and 1 year post transplant is an independent risk factor for the development of chronic renal failure and end stage renal disease after orthotopic liver transplantation. 24 patients will be randomized into 2 arms:
Arm A: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm B: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
Follow up: 2 years.
Arm A: Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Arm B: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
Follow up: 2 years.
Conditions
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Immunosuppression
Renal Failure
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Calcineurin Inhibitor with Mycophenolic Acid
Calcineurin inhibitor immunosuppression with mycophenolic acid
Group Type
ACTIVE_COMPARATOR
Calcineurin Inhibitor
Intervention Type
DRUG
Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
Everolimus with Mycophenolic Acid
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Group Type
EXPERIMENTAL
Arm A: Everolimus
Intervention Type
DRUG
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Interventions
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Arm A: Everolimus
Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
Intervention Type
DRUG
Calcineurin Inhibitor
Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
Intervention Type
DRUG
Other Intervention Names
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Zortress; Mycophenolic Acid (Myfortic)
Tacrolimus (Prograf)
Cyclosporine (Gengraf)
Mycophenolic Acid (Myfortic)
Eligibility Criteria
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Inclusion Criteria
* Ability and willingness to provide written informed consent and adhere to study regimen.
* Primary deceased donor liver transplant recipients 18-70 years of age
* Functioning allograft at randomization (AST, ALT, Total Bilirubin levels ≤3 times ULN, and AlkP and GGT levels ≤ 5 times ULN). Elevated GGT alone, in combination with AST, ALT, total bilirubin and AlkP within defined range does not exclude patients from randomization.
* Recipients on an immunosuppressive regimen of corticosteroids and tacrolimus.
* Confirmed recipient HCV status at Screening (either by serology or PCR).
* Abbreviated MDRD eGFR ≥ 30 mL/min/1.73m2. Local and central serum creatinine results within 5 days prior to randomization, however no sooner than Day 25 post-transplantation.
* Verification of at least one tacrolimus trough level of ≥ 8 ng/mL one week prior to randomization. Target trough levels above 8 ng/mL prior to randomization.
* Patients able to take oral medication at time of randomization.
* Primary deceased donor liver transplant recipients 18-70 years of age
* Functioning allograft at randomization (AST, ALT, Total Bilirubin levels ≤3 times ULN, and AlkP and GGT levels ≤ 5 times ULN). Elevated GGT alone, in combination with AST, ALT, total bilirubin and AlkP within defined range does not exclude patients from randomization.
* Recipients on an immunosuppressive regimen of corticosteroids and tacrolimus.
* Confirmed recipient HCV status at Screening (either by serology or PCR).
* Abbreviated MDRD eGFR ≥ 30 mL/min/1.73m2. Local and central serum creatinine results within 5 days prior to randomization, however no sooner than Day 25 post-transplantation.
* Verification of at least one tacrolimus trough level of ≥ 8 ng/mL one week prior to randomization. Target trough levels above 8 ng/mL prior to randomization.
* Patients able to take oral medication at time of randomization.
Exclusion Criteria
* Recipients of multiple solid organ or islet cell tissue transplants, or have previously received an organ or tissue transplant. Combined liver kidney transplant recipients.
* Living donor or split liver recipients.
* History of malignancy of any organ system within past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC.
* Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule ≤ 5 cm, 2-3 nodules all \< 3 cm, per explant histology of recipient liver.
* Use of antibody induction therapy.
* Patients with known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
* Recipients of ABO incompatible transplant grafts.
* Recipients of Hepatitis B surface antigen or HIV donor organs.
* Surgical or medical condition, which might significantly alter absorption, distribution, metabolism and excretion of study drug.
* Women of child-bearing potential (WOCBP): all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/m, or (2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy or (3) are using one or more of the following methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), copper coated IUD and double-barrier methods ( any double combination of male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout and for 3 months after study drug discontinuation.
* History of coagulopathy or medical condition requiring long-term anticoagulation which would preclude liver biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed).
Enrollment Exclusion - Randomization
* Severe hypercholesterolemia (\>350 mg/dL; \>9 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>8.5 mmol/L) within 6 months of transplantation. Controlled hyperlipidemia is acceptable at time of randomization.
* Platelet count \< 50,000/mm3 at randomization.
* Absolute neutrophil count \< 1,000/mm³ or white blood cell count \<2,000/mm³ at randomization.
* Patients positive for HIV: Negative laboratory results within 6 months before randomization are acceptable.
* Clinically significant systemic infection requiring IV antibiotics at randomization. Patients in a critical care setting at randomization requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents.
* Patients on renal replacement therapy within 7 days prior to randomization.
* Thrombosis of major hepatic arteries, major hepatic veins, portal vein and inferior vena cava. Results obtained within 5 days prior to randomization are acceptable, however no sooner than Day 25 post-transplantation.
* Acute rejection requiring antibody therapy or more than one steroid sensitive episode of acute rejection during the run-in period. Includes patients who have not completed steroid treatment for acute rejection within 7 days prior to randomization.
* Living donor or split liver recipients.
* History of malignancy of any organ system within past 5 years whether or not there is evidence of local recurrence or metastases, other than non-metastatic basal or squamous cell carcinoma of the skin or HCC.
* Hepatocellular carcinoma that does not fulfill Milan criteria (1 nodule ≤ 5 cm, 2-3 nodules all \< 3 cm, per explant histology of recipient liver.
* Use of antibody induction therapy.
* Patients with known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
* Recipients of ABO incompatible transplant grafts.
* Recipients of Hepatitis B surface antigen or HIV donor organs.
* Surgical or medical condition, which might significantly alter absorption, distribution, metabolism and excretion of study drug.
* Women of child-bearing potential (WOCBP): all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \>40 mIU/m, or (2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy or (3) are using one or more of the following methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), copper coated IUD and double-barrier methods ( any double combination of male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout and for 3 months after study drug discontinuation.
* History of coagulopathy or medical condition requiring long-term anticoagulation which would preclude liver biopsy after transplantation. (Low dose aspirin treatment or interruption of chronic anticoagulant is allowed).
Enrollment Exclusion - Randomization
* Severe hypercholesterolemia (\>350 mg/dL; \>9 mmol/L) or hypertriglyceridemia (\>500 mg/dL; \>8.5 mmol/L) within 6 months of transplantation. Controlled hyperlipidemia is acceptable at time of randomization.
* Platelet count \< 50,000/mm3 at randomization.
* Absolute neutrophil count \< 1,000/mm³ or white blood cell count \<2,000/mm³ at randomization.
* Patients positive for HIV: Negative laboratory results within 6 months before randomization are acceptable.
* Clinically significant systemic infection requiring IV antibiotics at randomization. Patients in a critical care setting at randomization requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents.
* Patients on renal replacement therapy within 7 days prior to randomization.
* Thrombosis of major hepatic arteries, major hepatic veins, portal vein and inferior vena cava. Results obtained within 5 days prior to randomization are acceptable, however no sooner than Day 25 post-transplantation.
* Acute rejection requiring antibody therapy or more than one steroid sensitive episode of acute rejection during the run-in period. Includes patients who have not completed steroid treatment for acute rejection within 7 days prior to randomization.
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Sponsor Role
collaborator
Milton S. Hershey Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Zakiyah Kadry
Professor of Surgery; Chief, Division of Transplantation
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Zakiyah Kadry, MD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine; Penn State Milton S Hershey Medical Center
Locations
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Penn State College of Medicine; Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Site Status
Countries
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United States
References
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Burra P, Senzolo M, Masier A, Prestele H, Jones R, Samuel D, Villamil F. Factors influencing renal function after liver transplantation. Results from the MOST, an international observational study. Dig Liver Dis. 2009 May;41(5):350-6. doi: 10.1016/j.dld.2008.09.018. Epub 2008 Nov 28.
Reference Type
BACKGROUND
Gonwa TA, Mai ML, Melton LB, Hays SR, Goldstein RM, Levy MF, Klintmalm GB. End-stage renal disease (ESRD) after orthotopic liver transplantation (OLTX) using calcineurin-based immunotherapy: risk of development and treatment. Transplantation. 2001 Dec 27;72(12):1934-9. doi: 10.1097/00007890-200112270-00012.
Reference Type
BACKGROUND
Ojo AO, Held PJ, Port FK, Wolfe RA, Leichtman AB, Young EW, Arndorfer J, Christensen L, Merion RM. Chronic renal failure after transplantation of a nonrenal organ. N Engl J Med. 2003 Sep 4;349(10):931-40. doi: 10.1056/NEJMoa021744.
Reference Type
BACKGROUND
Velidedeoglu E, Bloom RD, Crawford MD, Desai NM, Campos L, Abt PL, Markmann JW, Mange KC, Olthoff KM, Shaked A, Markmann JF. Early kidney dysfunction post liver transplantation predicts late chronic kidney disease. Transplantation. 2004 Feb 27;77(4):553-6. doi: 10.1097/01.tp.0000114609.99558.41.
Reference Type
BACKGROUND
Wadei HM, Geiger XJ, Cortese C, Mai ML, Kramer DJ, Rosser BG, Keaveny AP, Willingham DL, Ahsan N, Gonwa TA. Kidney allocation to liver transplant candidates with renal failure of undetermined etiology: role of percutaneous renal biopsy. Am J Transplant. 2008 Dec;8(12):2618-26. doi: 10.1111/j.1600-6143.2008.02426.x.
Reference Type
BACKGROUND
Randhawa PS, Shapiro R. Chronic renal failure after liver transplantation. Am J Transplant. 2005 May;5(5):967-8. doi: 10.1111/j.1600-6143.2005.00819.x. No abstract available.
Reference Type
BACKGROUND
McCauley J, Van Thiel DH, Starzl TE, Puschett JB. Acute and chronic renal failure in liver transplantation. Nephron. 1990;55(2):121-8. doi: 10.1159/000185938.
Reference Type
BACKGROUND
Fisher NC, Nightingale PG, Gunson BK, Lipkin GW, Neuberger JM. Chronic renal failure following liver transplantation: a retrospective analysis. Transplantation. 1998 Jul 15;66(1):59-66. doi: 10.1097/00007890-199807150-00010.
Reference Type
BACKGROUND
Neuberger JM, Mamelok RD, Neuhaus P, Pirenne J, Samuel D, Isoniemi H, Rostaing L, Rimola A, Marshall S, Mayer AD; ReSpECT Study Group. Delayed introduction of reduced-dose tacrolimus, and renal function in liver transplantation: the 'ReSpECT' study. Am J Transplant. 2009 Feb;9(2):327-36. doi: 10.1111/j.1600-6143.2008.02493.x. Epub 2008 Dec 15.
Reference Type
BACKGROUND
Chapman TM, Perry CM. Everolimus. Drugs. 2004;64(8):861-72; discussion 873-4. doi: 10.2165/00003495-200464080-00005.
Reference Type
BACKGROUND
Levy G, Schmidli H, Punch J, Tuttle-Newhall E, Mayer D, Neuhaus P, Samuel D, Nashan B, Klempnauer J, Langnas A, Calmus Y, Rogiers X, Abecassis M, Freeman R, Sloof M, Roberts J, Fischer L. Safety, tolerability, and efficacy of everolimus in de novo liver transplant recipients: 12- and 36-month results. Liver Transpl. 2006 Nov;12(11):1640-8. doi: 10.1002/lt.20707.
Reference Type
BACKGROUND
Nashan B. Early clinical experience with a novel rapamycin derivative. Ther Drug Monit. 2002 Feb;24(1):53-8. doi: 10.1097/00007691-200202000-00010.
Reference Type
BACKGROUND
Chan L, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, Shaw LM, Munir L, Ulbricht B, Cooper M; CRADUS09 Study Group. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation. 2008 Mar 27;85(6):821-6. doi: 10.1097/TP.0b013e318166927b.
Reference Type
BACKGROUND
Everson GT. Everolimus and mTOR inhibitors in liver transplantation: opening the "box". Liver Transpl. 2006 Nov;12(11):1571-3. doi: 10.1002/lt.20845. No abstract available.
Reference Type
BACKGROUND
De Simone P, Carrai P, Precisi A, Petruccelli S, Baldoni L, Balzano E, Ducci J, Caneschi F, Coletti L, Campani D, Filipponi F. Conversion to everolimus monotherapy in maintenance liver transplantation: feasibility, safety, and impact on renal function. Transpl Int. 2009 Mar;22(3):279-86. doi: 10.1111/j.1432-2277.2008.00768.x. Epub 2008 Dec 2.
Reference Type
BACKGROUND
Johnson RW, Kreis H, Oberbauer R, Brattstrom C, Claesson K, Eris J. Sirolimus allows early cyclosporine withdrawal in renal transplantation resulting in improved renal function and lower blood pressure. Transplantation. 2001 Sep 15;72(5):777-86. doi: 10.1097/00007890-200109150-00007.
Reference Type
BACKGROUND
Oberbauer R, Segoloni G, Campistol JM, Kreis H, Mota A, Lawen J, Russ G, Grinyo JM, Stallone G, Hartmann A, Pinto JR, Chapman J, Burke JT, Brault Y, Neylan JF; Rapamune Maintenance Regimen Study Group. Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation. Transpl Int. 2005 Jan;18(1):22-8. doi: 10.1111/j.1432-2277.2004.00052.x.
Reference Type
BACKGROUND
Ekberg H. Calcineurin inhibitor sparing in renal transplantation. Transplantation. 2008 Sep 27;86(6):761-7. doi: 10.1097/TP.0b013e3181856f39.
Reference Type
BACKGROUND
Baboolal K. A phase III prospective, randomized study to evaluate concentration-controlled sirolimus (rapamune) with cyclosporine dose minimization or elimination at six months in de novo renal allograft recipients. Transplantation. 2003 Apr 27;75(8):1404-8. doi: 10.1097/01.TP.0000063703.32564.3B.
Reference Type
BACKGROUND
Webster AC, Lee VW, Chapman JR, Craig JC. Target of rapamycin inhibitors (sirolimus and everolimus) for primary immunosuppression of kidney transplant recipients: a systematic review and meta-analysis of randomized trials. Transplantation. 2006 May 15;81(9):1234-48. doi: 10.1097/01.tp.0000219703.39149.85.
Reference Type
BACKGROUND
Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sorensen K, Hummel M, Lind JM, Abeywickrama KH, Bernhardt P; RAD B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003 Aug 28;349(9):847-58. doi: 10.1056/NEJMoa022171.
Reference Type
BACKGROUND
Levy GA, Grant D, Paradis K, Campestrini J, Smith T, Kovarik JM. Pharmacokinetics and tolerability of 40-0-[2-hydroxyethyl]rapamycin in de novo liver transplant recipients. Transplantation. 2001 Jan 15;71(1):160-3. doi: 10.1097/00007890-200101150-00028.
Reference Type
BACKGROUND
Gomez-Camarero J, Salcedo M, Rincon D, Lo Iacono O, Ripoll C, Hernando A, Sanz C, Clemente G, Banares R. Use of everolimus as a rescue immunosuppressive therapy in liver transplant patients with neoplasms. Transplantation. 2007 Sep 27;84(6):786-91. doi: 10.1097/01.tp.0000280549.93403.dd.
Reference Type
BACKGROUND
Yu SF, Wu LH, Zheng SS. Genetic factors for individual administration of immunosuppressants in organ transplantation. Hepatobiliary Pancreat Dis Int. 2006 Aug;5(3):337-44.
Reference Type
BACKGROUND
Chaudhary MA, Stearns SC. Estimating confidence intervals for cost-effectiveness ratios: an example from a randomized trial. Stat Med. 1996 Jul 15;15(13):1447-58. doi: 10.1002/(SICI)1097-0258(19960715)15:133.0.CO;2-V.
Reference Type
BACKGROUND
Willan AR, O'Brien BJ. Confidence intervals for cost-effectiveness ratios: an application of Fieller's theorem. Health Econ. 1996 Jul-Aug;5(4):297-305. doi: 10.1002/(SICI)1099-1050(199607)5:43.0.CO;2-T.
Reference Type
BACKGROUND
Briggs AH, Wonderling DE, Mooney CZ. Pulling cost-effectiveness analysis up by its bootstraps: a non-parametric approach to confidence interval estimation. Health Econ. 1997 Jul-Aug;6(4):327-40. doi: 10.1002/(sici)1099-1050(199707)6:43.0.co;2-w.
Reference Type
BACKGROUND
Lothgren M, Zethraeus N. Definition, interpretation and calculation of cost-effectiveness acceptability curves. Health Econ. 2000 Oct;9(7):623-30. doi: 10.1002/1099-1050(200010)9:73.0.co;2-v.
Reference Type
BACKGROUND
Fairbanks KD, Eustace JA, Fine D, Thuluvath PJ. Renal function improves in liver transplant recipients when switched from a calcineurin inhibitor to sirolimus. Liver Transpl. 2003 Oct;9(10):1079-85. doi: 10.1053/jlts.2003.50183.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRB 38115
Identifier Type: -
Identifier Source: org_study_id
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