Cardiovascular Risk Following Conversion to Full Dose Myfortic® and Neoral® Two-hour Post Level Monitoring
NCT ID: NCT02058875
Last Updated: 2017-01-09
Study Results
Results pending
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.
Recruitment Status
WITHDRAWN
Clinical Phase
PHASE4
Study Classification
INTERVENTIONAL
Study Start Date
2014-02-28
Study Completion Date
2015-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The overall goal of this study is to improve cardiovascular outcomes in transplant recipients. The current standard immunosuppressive regimen in kidney transplant recipients depends on a higher exposure to the Calcineurin Inhibitor (CNI), and often a less than optimal dosage the of mycophenolic acid (MPA) derivative. The premise of this study is to investigate the effects of reversing this paradigm. More specifically, the effect of using maximum MPA dosages (in the form of enteric-coated mycophenolate sodium \[EC-MPS\] or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) will be investigated.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prospective, 6 Month, Open Label, Conversion Study From Mycophenolate Mofetil (MMF) to PRMYFORTIC*
NCT00715468
Late Complication From Kidney Transplant
COMPLETED
Mycophenolate Mofetil for Reducing Cardiovascular Risk in Renal Transplant Recipients
NCT01213394
Kidney Transplantation
Cardiovascular Diseases
TERMINATED
PHASE3
Kidney Graft Function Under the Immunosuppression Strategies
NCT01817322
Chronic Renal Disease
COMPLETED
PHASE4
Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients
NCT00574197
Gastrointestinal Symptoms
Heart Transplantation
COMPLETED
PHASE4
Myfortic vs. Cellcept in Kidney Transplant Recipients
NCT00533624
End Stage Renal Disease
COMPLETED
PHASE2/PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Research Question:
Will treating kidney transplant recipients with maximum MPA dosages (in the form of EC-MPS or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) lead to improved cardiovascular outcomes, as measured by the Framingham Risk Score, 7-year major adverse cardiac events (MACE) score and cardiovascular risk inflammatory biomarker profile?
Primary Objectives:
1. To improve the Framingham Risk Score and 7-year MACE score for renal transplant recipients, which estimate risk for cardiovascular disease.
2. To improve the cardiovascular risk inflammatory biomarker profile.
Hypothesis:
The more consistent drug exposure and lower Cmax noted with monitoring cyclosporine using the 2h levels (C2) combined with full dose Myfortic® will decrease Framingham Risk Score, MACE score, as well as markers of inflammation in kidney transplant recipients because:
1. CNI minimization protocols are widely accepted as a strategy to ameliorate allograft and vascular injury.
2. Chronic allograft injury and vascular disease are known inflammatory conditions.
3. The MPA derivatives possess significant anti-inflammatory properties.
Will treating kidney transplant recipients with maximum MPA dosages (in the form of EC-MPS or Myfortic®) along with judicious CNI exposure (cyclosporine/Neoral®) lead to improved cardiovascular outcomes, as measured by the Framingham Risk Score, 7-year major adverse cardiac events (MACE) score and cardiovascular risk inflammatory biomarker profile?
Primary Objectives:
1. To improve the Framingham Risk Score and 7-year MACE score for renal transplant recipients, which estimate risk for cardiovascular disease.
2. To improve the cardiovascular risk inflammatory biomarker profile.
Hypothesis:
The more consistent drug exposure and lower Cmax noted with monitoring cyclosporine using the 2h levels (C2) combined with full dose Myfortic® will decrease Framingham Risk Score, MACE score, as well as markers of inflammation in kidney transplant recipients because:
1. CNI minimization protocols are widely accepted as a strategy to ameliorate allograft and vascular injury.
2. Chronic allograft injury and vascular disease are known inflammatory conditions.
3. The MPA derivatives possess significant anti-inflammatory properties.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cardiovascular Disease
Cardiovascular Outcomes
Kidney Transplant Recipients
Kidney Transplantation
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Group
Maximization of mycophenolicacid (MPA) derivative (to a total daily dosage of 1440mg of Myfortic®) and reduction of cyclosporine dosage (as defined by C2 monitoring) in 50 stable renal transplant patients previously on immunosuppressive therapy with cyclosporine, an MPA derivative and prednisone.
Group Type
EXPERIMENTAL
Myfortic®
Intervention Type
DRUG
Neoral®
Intervention Type
DRUG
Control Group
25 patients continued on an mycophenolicacid (MPA) derivative, cyclosporine and prednisone.
Group Type
ACTIVE_COMPARATOR
Myfortic®
Intervention Type
DRUG
Cellcept®
Intervention Type
DRUG
Prednisone
Intervention Type
DRUG
Observation Group
25 patients continued on an mycophenolic acid (MPA) derivative, tacrolimus, and prednisone will be followed during the same recruitment period as an additional comparison, as this is the other Calcineurin Inhibitor (CNI), which is used in kidney transplantation.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Myfortic®
Intervention Type
DRUG
Neoral®
Intervention Type
DRUG
Cellcept®
Intervention Type
DRUG
Prednisone
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
mycophenolate sodium
MPA derivative
cyclosporine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Kidney transplant patients followed as outpatients who are currently stabilized on immunosuppressive therapy with an MPA derivative, a CNI and prednisone where stability is defined as change in serum creatinine of less than 10% or over the last three months.
2. Age 18-74 years old.
3. At least six months after transplantation.
4. Lack of transplant rejection within the last 12 weeks.
5. Serum creatinine less than 300 umol/L at enrolment.
6. Negative urine pregnancy test for female patients of childbearing potential.
7. Consent to the study.
8. Not included in another interventional clinical trial within the last 90 days.
2. Age 18-74 years old.
3. At least six months after transplantation.
4. Lack of transplant rejection within the last 12 weeks.
5. Serum creatinine less than 300 umol/L at enrolment.
6. Negative urine pregnancy test for female patients of childbearing potential.
7. Consent to the study.
8. Not included in another interventional clinical trial within the last 90 days.
Exclusion Criteria
1. Patients with other types of solid organ transplants.
2. Patients with any form of substance abuse or major psychiatric disorder.
3. Patients with acute or chronic diarrhea, known bowel disease or known gastroparesis.
4. Patients receiving anti-lymphocyte treatment for rejection within the last six months.
5. Patients not receiving a mycophenolic acid derivative.
6. Patients who do not tolerate the maximum Myfortic® total daily dose of 1440 mg OD.
7. Patients with significant liver disease defined as having an elevated bilirubin by at least two times the upper value of the normal range.
8. Patients who have any unstable medical condition that could interfere with the study.
9. Patients with chronic viral infection with HIV, Hepatitis B \& C.
10. Presence of any acute illness requiring admission to the hospital for the last 4 weeks.
11. Pregnancy.
12. Significant cardiovascular event such as MI, stroke or TIA within the last 12 weeks or uncontrolled hypertension.
13. Immunosuppressant changes within the last month.
2. Patients with any form of substance abuse or major psychiatric disorder.
3. Patients with acute or chronic diarrhea, known bowel disease or known gastroparesis.
4. Patients receiving anti-lymphocyte treatment for rejection within the last six months.
5. Patients not receiving a mycophenolic acid derivative.
6. Patients who do not tolerate the maximum Myfortic® total daily dose of 1440 mg OD.
7. Patients with significant liver disease defined as having an elevated bilirubin by at least two times the upper value of the normal range.
8. Patients who have any unstable medical condition that could interfere with the study.
9. Patients with chronic viral infection with HIV, Hepatitis B \& C.
10. Presence of any acute illness requiring admission to the hospital for the last 4 weeks.
11. Pregnancy.
12. Significant cardiovascular event such as MI, stroke or TIA within the last 12 weeks or uncontrolled hypertension.
13. Immunosuppressant changes within the last month.
Minimum Eligible Age
18 Years
Maximum Eligible Age
74 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Saskatchewan
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
AShoker
M.D.
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahmed Shoker, MD
Role: PRINCIPAL_INVESTIGATOR
University of Saskatchewan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kidney Health Center
Regina, Saskatchewan, Canada
Site Status
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Canada
References
Explore related publications, articles, or registry entries linked to this study.
Ojo AO. Cardiovascular complications after renal transplantation and their prevention. Transplantation. 2006 Sep 15;82(5):603-11. doi: 10.1097/01.tp.0000235527.81917.fe.
Reference Type
BACKGROUND
Barama A, Sepandj F, Gough J, McKenna R. Correlation between Neoral 2 hours post-dose levels and histologic findings on surveillance biopsies. Transplant Proc. 2004 Mar;36(2 Suppl):465S-467S. doi: 10.1016/j.transproceed.2003.12.039.
Reference Type
BACKGROUND
Behrend M, Braun F. Enteric-coated mycophenolate sodium: tolerability profile compared with mycophenolate mofetil. Drugs. 2005;65(8):1037-50. doi: 10.2165/00003495-200565080-00001.
Reference Type
BACKGROUND
Bolin P Jr, Gohh R, Kandaswamy R, Shihab FS, Wiland A, Akhlaghi F, Melancon K. Mycophenolic acid in kidney transplant patients with diabetes mellitus: does the formulation matter? Transplant Rev (Orlando). 2011 Jul;25(3):117-23. doi: 10.1016/j.trre.2010.12.003. Epub 2011 Apr 29.
Reference Type
BACKGROUND
Carstens J. Three-years experience with Neoral C2 monitoring adjusted to a target range of 500-600 ng/ml in long-term renal transplant recipients receiving dual immunosuppressive therapy. Scand J Urol Nephrol. 2008;42(3):286-92. doi: 10.1080/00365590701748039.
Reference Type
BACKGROUND
Cibrik D, Meier-Kriesche HU, Bresnahan B, Wu YM, Klintmalm G, Kew CE, Kuo PC, Whelchel J, Cohen D, Baliga P, Akalin E, Benedetti E, Wright F, Lieberman B, Ulbricht B, Jensik S; Myfortic-US01 Renal Transplant Study Group. Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients. Clin Transplant. 2007 Mar-Apr;21(2):192-201. doi: 10.1111/j.1399-0012.2006.00622.x.
Reference Type
BACKGROUND
Citterio F. Evolution of the therapeutic drug monitoring of cyclosporine. Transplant Proc. 2004 Mar;36(2 Suppl):420S-425S. doi: 10.1016/j.transproceed.2004.01.054.
Reference Type
BACKGROUND
Cuero C, Delgado E, de Gonzalez M, Medina C, Vernaza A, Moscoso J. [C0 vs C2 levels and their implications in kidney transplantation]. Rev Med Panama. 2002;27:30-3. Spanish.
Reference Type
BACKGROUND
Dominguez J, Fuenzalida D, Norambuena R, Pais E, Cortes Monroy G, Llanos R. C2 monitoring of cyclosporine in stable renal transplant patients results in lower costs and improved renal function. Transplant Proc. 2005 Apr;37(3):1583-5. doi: 10.1016/j.transproceed.2004.09.016.
Reference Type
BACKGROUND
Gozdowska J, Urbanowicz AL, Galazka Z, Chmura A, Durlik M. Tolerance of enteric-coated mycophenolate sodium in combination with calcineurin inhibitor in kidney transplant recipients: Polish experience. Transplant Proc. 2011 Oct;43(8):2946-9. doi: 10.1016/j.transproceed.2011.08.056.
Reference Type
BACKGROUND
Hernandez D, Moreso F. Has patient survival following renal transplantation improved in the era of modern immunosuppression? Nefrologia. 2013;33(2):171-80. doi: 10.3265/Nefrologia.pre2012.Nov.11743. English, Spanish.
Reference Type
BACKGROUND
Hoorn EJ, Walsh SB, McCormick JA, Furstenberg A, Yang CL, Roeschel T, Paliege A, Howie AJ, Conley J, Bachmann S, Unwin RJ, Ellison DH. The calcineurin inhibitor tacrolimus activates the renal sodium chloride cotransporter to cause hypertension. Nat Med. 2011 Oct 2;17(10):1304-9. doi: 10.1038/nm.2497.
Reference Type
BACKGROUND
Jardine AG, Fellstrom B, Logan JO, Cole E, Nyberg G, Gronhagen-Riska C, Madsen S, Neumayer HH, Maes B, Ambuhl P, Olsson AG, Pedersen T, Holdaas H. Cardiovascular risk and renal transplantation: post hoc analyses of the Assessment of Lescol in Renal Transplantation (ALERT) Study. Am J Kidney Dis. 2005 Sep;46(3):529-36. doi: 10.1053/j.ajkd.2005.05.014.
Reference Type
BACKGROUND
Kahan BD, Podbielski J, Childs B. The impact of conversion from mycophenolate mofetil to mycophenolate sodium among renal transplant recipients on a sirolimus-based regimen. Transplant Proc. 2008 Jun;40(5):1429-34. doi: 10.1016/j.transproceed.2008.04.009.
Reference Type
BACKGROUND
Kamar N, Rostaing L, Cassuto E, Villemain F, Moal MC, Ladriere M, Barrou B, Ducloux D, Chaouche K, Quere S, Di Giambattista F, Be F. A multicenter, randomized trial of increased mycophenolic acid dose using enteric-coated mycophenolate sodium with reduced tacrolimus exposure in maintenance kidney transplant recipients. Clin Nephrol. 2012 Feb;77(2):126-36. doi: 10.5414/CN107227.
Reference Type
BACKGROUND
Kockx M, Jessup W, Kritharides L. Cyclosporin A and atherosclerosis--cellular pathways in atherogenesis. Pharmacol Ther. 2010 Oct;128(1):106-18. doi: 10.1016/j.pharmthera.2010.06.001. Epub 2010 Jun 18.
Reference Type
BACKGROUND
Langone AJ, Chan L, Bolin P, Cooper M. Enteric-coated mycophenolate sodium versus mycophenolate mofetil in renal transplant recipients experiencing gastrointestinal intolerance: a multicenter, double-blind, randomized study. Transplantation. 2011 Feb 27;91(4):470-8. doi: 10.1097/TP.0b013e318205568c.
Reference Type
BACKGROUND
Luft FC. How calcineurin inhibitors cause hypertension. Nephrol Dial Transplant. 2012 Feb;27(2):473-5. doi: 10.1093/ndt/gfr679. Epub 2011 Dec 15. No abstract available.
Reference Type
BACKGROUND
Meneses Rde P, Kotsifas CH. Benefits of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in pediatric renal transplant patients with stable graft function. Pediatr Transplant. 2009 Mar;13(2):188-93. doi: 10.1111/j.1399-3046.2008.00977.x. Epub 2008 Jul 30.
Reference Type
BACKGROUND
Nart A, Sipahi S, Aykas A, Uslu A, Hoscoskun C, Toz H. Efficacy and safety of enteric-coated mycophenolate sodium in de novo and maintenance renal transplant patients. Transplant Proc. 2008 Jan-Feb;40(1):189-92. doi: 10.1016/j.transproceed.2007.11.066.
Reference Type
BACKGROUND
Nashan B, Ivens K, Suwelack B, Arns W, Abbud Filho M; myPROMS DE02 Study Group; LA01 Study Group. Conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in maintenance renal transplant patients: preliminary results from the myfortic prospective multicenter study. Transplant Proc. 2004 Mar;36(2 Suppl):521S-523S. doi: 10.1016/j.transproceed.2004.01.037.
Reference Type
BACKGROUND
Nemati E, Einollahi B, Taheri S, Moghani-Lankarani M, Kalantar E, Simforoosh N, Nafar M, Saadat AR. Cyclosporine trough (C0) and 2-hour postdose (C2) levels: which one is a predictor of graft loss? Transplant Proc. 2007 May;39(4):1223-4. doi: 10.1016/j.transproceed.2007.02.005.
Reference Type
BACKGROUND
Ponticelli C. Generic cyclosporine: a word of caution. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S20-4.
Reference Type
BACKGROUND
Ponticelli C, Cucchiari D, Graziani G. Hypertension in kidney transplant recipients. Transpl Int. 2011 Jun;24(6):523-33. doi: 10.1111/j.1432-2277.2011.01242.x. Epub 2011 Mar 8.
Reference Type
BACKGROUND
Sabbatini M, Capone D, Gallo R, Pisani A, Polichetti G, Tarantino G, Gentile A, Rotaia E, Federico S. EC-MPS permits lower gastrointestinal symptom burden despite higher MPA exposure in patients with severe MMF-related gastrointestinal side-effects. Fundam Clin Pharmacol. 2009 Oct;23(5):617-24. doi: 10.1111/j.1472-8206.2009.00711.x. Epub 2009 Jul 28.
Reference Type
BACKGROUND
Soveri I, Holdaas H, Jardine A, Gimpelewicz C, Staffler B, Fellstrom B. Renal transplant dysfunction--importance quantified in comparison with traditional risk factors for cardiovascular disease and mortality. Nephrol Dial Transplant. 2006 Aug;21(8):2282-9. doi: 10.1093/ndt/gfl095. Epub 2006 Mar 30.
Reference Type
BACKGROUND
Textor SC, Taler SJ, Canzanello VJ, Schwartz L, Augustine JE. Posttransplantation hypertension related to calcineurin inhibitors. Liver Transpl. 2000 Sep;6(5):521-30. doi: 10.1053/jlts.2000.9737.
Reference Type
BACKGROUND
Watt KD. Metabolic syndrome: is immunosuppression to blame? Liver Transpl. 2011 Nov;17 Suppl 3:S38-42. doi: 10.1002/lt.22386.
Reference Type
BACKGROUND
Nankivell BJ, Chapman JR. Chronic allograft nephropathy: current concepts and future directions. Transplantation. 2006 Mar 15;81(5):643-54. doi: 10.1097/01.tp.0000190423.82154.01.
Reference Type
BACKGROUND
White SL, Polkinghorne KR, Atkins RC, Chadban SJ. Comparison of the prevalence and mortality risk of CKD in Australia using the CKD Epidemiology Collaboration (CKD-EPI) and Modification of Diet in Renal Disease (MDRD) Study GFR estimating equations: the AusDiab (Australian Diabetes, Obesity and Lifestyle) Study. Am J Kidney Dis. 2010 Apr;55(4):660-70. doi: 10.1053/j.ajkd.2009.12.011.
Reference Type
BACKGROUND
Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009 Oct;25(10):567-79. doi: 10.1016/s0828-282x(09)70715-9.
Reference Type
BACKGROUND
D'Agostino RB Sr, Vasan RS, Pencina MJ, Wolf PA, Cobain M, Massaro JM, Kannel WB. General cardiovascular risk profile for use in primary care: the Framingham Heart Study. Circulation. 2008 Feb 12;117(6):743-53. doi: 10.1161/CIRCULATIONAHA.107.699579. Epub 2008 Jan 22.
Reference Type
BACKGROUND
Kasiske BL, Chakkera HA, Roel J. Explained and unexplained ischemic heart disease risk after renal transplantation. J Am Soc Nephrol. 2000 Sep;11(9):1735-1743. doi: 10.1681/ASN.V1191735.
Reference Type
BACKGROUND
Ducloux D, Kazory A, Chalopin JM. Predicting coronary heart disease in renal transplant recipients: a prospective study. Kidney Int. 2004 Jul;66(1):441-7. doi: 10.1111/j.1523-1755.2004.00751.x.
Reference Type
BACKGROUND
Kiberd B, Panek R. Cardiovascular outcomes in the outpatient kidney transplant clinic: the Framingham risk score revisited. Clin J Am Soc Nephrol. 2008 May;3(3):822-8. doi: 10.2215/CJN.00030108. Epub 2008 Mar 5.
Reference Type
BACKGROUND
Silver SA, Huang M, Nash MM, Prasad GV. Framingham risk score and novel cardiovascular risk factors underpredict major adverse cardiac events in kidney transplant recipients. Transplantation. 2011 Jul 27;92(2):183-9. doi: 10.1097/TP.0b013e31821f303f.
Reference Type
BACKGROUND
Israni AK, Snyder JJ, Skeans MA, Peng Y, Maclean JR, Weinhandl ED, Kasiske BL; PORT Investigators. Predicting coronary heart disease after kidney transplantation: Patient Outcomes in Renal Transplantation (PORT) Study. Am J Transplant. 2010 Feb;10(2):338-53. doi: 10.1111/j.1600-6143.2009.02949.x.
Reference Type
BACKGROUND
Soveri I, Holme I, Holdaas H, Budde K, Jardine AG, Fellstrom B. A cardiovascular risk calculator for renal transplant recipients. Transplantation. 2012 Jul 15;94(1):57-62. doi: 10.1097/TP.0b013e3182516cdc.
Reference Type
BACKGROUND
Soveri I, Snyder J, Holdaas H, Holme I, Jardine AG, L'Italien GJ, Fellstrom B. The external validation of the cardiovascular risk equation for renal transplant recipients: applications to BENEFIT and BENEFIT-EXT trials. Transplantation. 2013 Jan 15;95(1):142-7. doi: 10.1097/TP.0b013e31827722c9.
Reference Type
BACKGROUND
Holdaas H, Fellstrom B, Jardine AG, Holme I, Nyberg G, Fauchald P, Gronhagen-Riska C, Madsen S, Neumayer HH, Cole E, Maes B, Ambuhl P, Olsson AG, Hartmann A, Solbu DO, Pedersen TR; Assessment of LEscol in Renal Transplantation (ALERT) Study Investigators. Effect of fluvastatin on cardiac outcomes in renal transplant recipients: a multicentre, randomised, placebo-controlled trial. Lancet. 2003 Jun 14;361(9374):2024-31. doi: 10.1016/S0140-6736(03)13638-0.
Reference Type
BACKGROUND
Tang SC, Chan KW, Tang CS, Lam MF, Leung CY, Tse KC, Li CS, Ho YW, Tong MK, Lai KN, Chan TM; Hong Kong Nephrology Study Group. Conversion of ciclosporin A to tacrolimus in kidney transplant recipients with chronic allograft nephropathy. Nephrol Dial Transplant. 2006 Nov;21(11):3243-51. doi: 10.1093/ndt/gfl397. Epub 2006 Jul 28.
Reference Type
BACKGROUND
Suwelack B, Gerhardt U, Hohage H. Withdrawal of cyclosporine or tacrolimus after addition of mycophenolate mofetil in patients with chronic allograft nephropathy. Am J Transplant. 2004 Apr;4(4):655-62. doi: 10.1111/j.1600-6143.2004.00404.x.
Reference Type
BACKGROUND
Jiang S, Tang Q, Rong R, Tang L, Xu M, Lu J, Jia Y, Ooi Y, Hou J, Guo J, Yang B, Zhu T. Mycophenolate mofetil inhibits macrophage infiltration and kidney fibrosis in long-term ischemia-reperfusion injury. Eur J Pharmacol. 2012 Aug 5;688(1-3):56-61. doi: 10.1016/j.ejphar.2012.05.001. Epub 2012 May 16.
Reference Type
BACKGROUND
Tedesco D, Haragsim L. Cyclosporine: a review. J Transplant. 2012;2012:230386. doi: 10.1155/2012/230386. Epub 2012 Jan 4.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CERL080ACA15T
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
NCT01169701
COMPLETED
PHASE4
Myfortic or CellCept Gastrointestinal Effects in African American Kidney Recipients
NCT00522548
TERMINATED
PHASE4
Freedom Study: Myfortic in Kidney Transplant Patients
NCT00101738
COMPLETED
PHASE3
Pharmacokinetic Profile of Myfortic in Combination With Tacrolimus in Fed Versus Fasting State
NCT00585468
COMPLETED
PHASE4
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
NCT00903188
UNKNOWN
PHASE4
Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk
NCT01702207
COMPLETED
PHASE4
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
NCT00097968
COMPLETED
PHASE3
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
NCT00098007
COMPLETED
PHASE3
Efficacy, Safety and Evolution of Cardiovascular Parameters in Renal Transplant Recipients
NCT01114529
COMPLETED
PHASE3
Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens
NCT00157014
COMPLETED
PHASE3
VIP: Vascular Imaging Project. Study on the Progression of Cardiovascular Disease in Renal Transplant Recipients
NCT00169910
COMPLETED
PHASE4
Efficacy and Safety of FTY720 in Patients Who Receive a Kidney Transplant
NCT00099736
COMPLETED
PHASE3
Comparison of Efficacy and Safety of Treatment With a Calcineurin Inhibitor (CNI)Versus a CNI-free Treatment in Renal Transplantation (CIME)
NCT01595984
UNKNOWN
PHASE3
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
NCT00170859
COMPLETED
PHASE4
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
NCT00332839
TERMINATED
PHASE4
Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation
NCT01467011
COMPLETED
Study in Recipients of Renal Transplant Allograft to Evaluate the Impact of Two Immunosuppressive Regimens
NCT01653847
COMPLETED
NA
A Trial Comparing Prograf and Neoral Use in Kidney Transplant Recipients of Hispanic Ethnicity
NCT00983645
TERMINATED
PHASE4
Pharmacokinetic Evaluation of an Intensified and Decreasing Dosing Regimen of Mycophenolate Sodium in Combination With Tacrolimus Post Kidney Transplant: The Myfortic Study
NCT00941824
COMPLETED
PHASE4
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients
NCT00965094
COMPLETED
PHASE4
Myfortic in Heart Transplant Patients With Gastrointestinal (GI) Symptoms
NCT00468936
UNKNOWN
PHASE3
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
NCT00064701
COMPLETED
PHASE3
Efficacy and Safety of FTY720 Versus Mycophenolate Mofetil (MMF, Roche Brand) in de Novo Adult Renal Transplant Recipients
NCT00239863
COMPLETED
PHASE3
A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients
NCT00862979
COMPLETED
PHASE4
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
NCT00239785
COMPLETED
PHASE3