Pilot Trial for Implementation of a MPA PK Monitoring Strategy
NCT ID: NCT00187915
Last Updated: 2011-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2003-07-31
2004-12-31
Brief Summary
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Detailed Description
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MMF significantly decreases the episodes of acute rejection in kidney transplant patients; but as with any medication without adequate pharmacokinetic drug monitoring, the issue of under or over immunosuppression arises. For this reason, the biggest challenge lies with establishing a feasible mean of MPA pharmacokinetic monitoring. Thus far no study has shown that measuring MPA trough levels alone correlates with rejection, unlike MPA Area Under the concentration time Curve (AUC), due to the large incidence of inter- and intra-patient variability.
This is the first prospective blinded trial set up to analyze the correlation between individualized MPA AUC and trough levels of kidney transplant patients in hopes of establishing a more efficacious way of monitoring MPA. MPA target trough levels that correspond to AUC greater than 30 mg x h/L could then be utilized as maintenance measurements.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CellCept + Prograf
Standard of Care Regime
Mycophenolate mofetil + Tacrolimus
Target MPA exposure to 30-60 mg/L/h during first month post-transplant
CellCept + Neoral
Standard of Care Regime
Mycophenolate mofetil + Cyclosporin
Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Interventions
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Mycophenolate mofetil + Tacrolimus
Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Mycophenolate mofetil + Cyclosporin
Target MPA exposure to 30-60 mg/L/h during first month post-transplant
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* On Cellcept
Exclusion Criteria
* Documented non-compliance
* Not on a calcineurin inhibitor
* GFR \<25 ml/min by Cockcroft Gault equation
* Serum albumin \<2.5 mg/dl
* Pregnant
* Active serious digestive disorder
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
University of Florida
OTHER
Responsible Party
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Principal Investigators
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Herwig-Ulf Meier-Kriesche, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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University of Florida
Gainesville, Florida, United States
Countries
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References
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Placebo-controlled study of mycophenolate mofetil combined with cyclosporin and corticosteroids for prevention of acute rejection. European Mycophenolate Mofetil Cooperative Study Group. Lancet. 1995 May 27;345(8961):1321-5.
Sollinger HW. Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U.S. Renal Transplant Mycophenolate Mofetil Study Group. Transplantation. 1995 Aug 15;60(3):225-32. doi: 10.1097/00007890-199508000-00003.
A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation. The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. Transplantation. 1996 Apr 15;61(7):1029-37.
Meier-Kriesche HU, Steffen BJ, Hochberg AM, Gordon RD, Liebman MN, Morris JA, Kaplan B. Long-term use of mycophenolate mofetil is associated with a reduction in the incidence and risk of late rejection. Am J Transplant. 2003 Jan;3(1):68-73. doi: 10.1034/j.1600-6143.2003.30112.x.
Meier-Kriesche HU, Steffen BJ, Hochberg AM, Gordon RD, Liebman MN, Morris JA, Kaplan B. Mycophenolate mofetil versus azathioprine therapy is associated with a significant protection against long-term renal allograft function deterioration. Transplantation. 2003 Apr 27;75(8):1341-6. doi: 10.1097/01.TP.0000062833.14843.4B.
Hale MD, Nicholls AJ, Bullingham RE, Hene R, Hoitsma A, Squifflet JP, Weimar W, Vanrenterghem Y, Van de Woude FJ, Verpooten GA. The pharmacokinetic-pharmacodynamic relationship for mycophenolate mofetil in renal transplantation. Clin Pharmacol Ther. 1998 Dec;64(6):672-83. doi: 10.1016/S0009-9236(98)90058-3.
van Gelder T, Hilbrands LB, Vanrenterghem Y, Weimar W, de Fijter JW, Squifflet JP, Hene RJ, Verpooten GA, Navarro MT, Hale MD, Nicholls AJ. A randomized double-blind, multicenter plasma concentration controlled study of the safety and efficacy of oral mycophenolate mofetil for the prevention of acute rejection after kidney transplantation. Transplantation. 1999 Jul 27;68(2):261-6. doi: 10.1097/00007890-199907270-00018.
van Gelder T, Shaw LM. The rationale for and limitations of therapeutic drug monitoring for mycophenolate mofetil in transplantation. Transplantation. 2005 Oct 15;80(2 Suppl):S244-53. doi: 10.1097/01.tp.0000186380.61251.fc.
Shaw LM, Mick R, Nowak I, Korecka M, Brayman KL. Pharmacokinetics of mycophenolic acid in renal transplant patients with delayed graft function. J Clin Pharmacol. 1998 Mar;38(3):268-75. doi: 10.1002/j.1552-4604.1998.tb04424.x.
van Gelder T, Klupp J, Barten MJ, Christians U, Morris RE. Comparison of the effects of tacrolimus and cyclosporine on the pharmacokinetics of mycophenolic acid. Ther Drug Monit. 2001 Apr;23(2):119-28. doi: 10.1097/00007691-200104000-00005.
Srinivas TR, Meier-Kriesche HU, Kaplan B. Pharmacokinetic principles of immunosuppressive drugs. Am J Transplant. 2005 Feb;5(2):207-17. doi: 10.1111/j.1600-6143.2005.00748.x.
Yamani MH, Starling RC, Goormastic M, Van Lente F, Smedira N, McCarthy P, Young JB. The impact of routine mycophenolate mofetil drug monitoring on the treatment of cardiac allograft rejection. Transplantation. 2000 Jun 15;69(11):2326-30. doi: 10.1097/00007890-200006150-00018.
Shaw LM, Pawinski T, Korecka M, Nawrocki A. Monitoring of mycophenolic acid in clinical transplantation. Ther Drug Monit. 2002 Feb;24(1):68-73. doi: 10.1097/00007691-200202000-00012. No abstract available.
Mourad M, Wallemacq P, Konig J, de Frahan EH, Eddour DC, De Meyer M, Malaise J, Squifflet JP. Therapeutic monitoring of mycophenolate mofetil in organ transplant recipients: is it necessary? Clin Pharmacokinet. 2002;41(5):319-27. doi: 10.2165/00003088-200241050-00001.
Cattaneo D, Perico N, Gaspari F, Gotti E, Remuzzi G. Glucocorticoids interfere with mycophenolate mofetil bioavailability in kidney transplantation. Kidney Int. 2002 Sep;62(3):1060-7. doi: 10.1046/j.1523-1755.2002.00531.x.
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. doi: 10.1034/j.1600-6143.2003.00079.x. No abstract available.
Cattaneo D, Gaspari F, Ferrari S, Stucchi N, Del Priore L, Perico N, Gotti E, Remuzzi G. Pharmacokinetics help optimizing mycophenolate mofetil dosing in kidney transplant patients. Clin Transplant. 2001 Dec;15(6):402-9. doi: 10.1034/j.1399-0012.2001.150607.x.
Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC. Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct 27;74(8):1070-6. doi: 10.1097/00007890-200210270-00002.
Other Identifiers
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20030499
Identifier Type: OTHER
Identifier Source: secondary_id
CEL330
Identifier Type: -
Identifier Source: org_study_id