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| ID | Type | Description | Link |
|---|---|---|---|
| CERL080ABR08T | Other Identifier | NOVARTIS |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The purpose of this study is investigate mycophenolic acid exposure through area under the curve in renal transplants recipients treated with mycophenolate mofetil and after conversion to mycophenolate sodium.
A growing body of evidence has shown that mycophenolate acid (MPA) exposure assessment and dosage adjustment are necessary in patients treated with mycophenolate mofetil (MMF), but there is still limited information about the dose-exposure-effect relationship of the enteric-coated mycophenolate sodium (EC-MPS) formulation that has quite different physicochemical properties (TETT et al., 2011).
Pharmacokinetically guided exposure-controlled area under the concentration-time curve (AUC) approaches are helpful to limit interpatient variability of MPA exposure and to improve the clinical outcome of organ transplant recipients (TETT et al., 2011).
MPA area under the concentration-time curve values between 30 and 60 μg h/mL in the early post-transplant period reduces the risk of acute rejections and seems to be appropriate in renal allograft recipients taking mycophenolate sodium (MPS) and calcineurin inhibitors (GRINYÓ et al., 2009; SOMMERER et al., 2010).
Among the benefits of therapeutic drug monitoring of MPA are the evaluation of interaction between MPA and proton pump inhibitors and association of donor-specific antibodies reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate sodium | Experimental | Arm1(Conversion):MPA AUC below 30mcg*h ml-1 - MPS+Calcineurin inhibitor+prednisone |
|
| Mycophenolate mofetil | Active Comparator | Arm2(Maintained):MPA AUC between 30 to 60 mg*h ml-1 or above 60 mg - MMF+Calcineurin inhibitor+prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate sodium | Drug | The conversion will be performed abruptly for all patients. Mycophenolate mofetil will be discontinued one day before the day of conversion (Day 1). Mycophenolate sodium will be introduced on day 1 with equivalent doses. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the frequency of renal transplants recipients taking mycophenolate mofetil (MMF) with MPA AUC below target level (30mcg*h ml-1). | Evaluate the frequency of renal transplants recipients taking mycophenolate mofetil (MMF) with MPA AUC below target level (30mcg*h ml-1). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the association of MPA AUC in renal transplant recipients with donor specific antibodies (DSA); | Evaluate the association of MPA AUC in renal transplant recipients with donor specific antibodies (DSA); | Baseline; month 6. |
| Evaluate the interaction between MMF or EC-MPS and the proton pump inhibitor omeprazole through the AUC in patients with MPA below target level (30mcg*h ml-1). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valter Garcia, Physician | IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE | Principal Investigator |
| Elizete Keitel, Physician | IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE | Study Chair |
| Daniela Seelig, Physician | IRMANDADE DA SANTA CASA DE MISERICÓRIDA DE PORTO ALEGRE | Study Chair |
| Fabiano Klaus, Physician | IRMANDADE DA SANTA CASA DE MISERICÓRIDA DE PORTO ALEGRE | Study Chair |
| Ronivan Dal Pra, Pharmacist | IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE | Study Director |
| Larissa Pacheco, Pharmacist | IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE | Study Director |
| Bruna Cardoso, Pharmacist | IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE | Study Director |
| Roger Kist, Trainee | IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE | Study Director |
| Helen Zanetti, Pharmacist | IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irmandade Da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020090 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21190834 | Background | Tett SE, Saint-Marcoux F, Staatz CE, Brunet M, Vinks AA, Miura M, Marquet P, Kuypers DR, van Gelder T, Cattaneo D. Mycophenolate, clinical pharmacokinetics, formulations, and methods for assessing drug exposure. Transplant Rev (Orlando). 2011 Apr;25(2):47-57. doi: 10.1016/j.trre.2010.06.001. Epub 2010 Dec 28. | |
| 19357111 | Background |
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| Mycophenolate mofetil | Drug | Mycophenolate mofetil dose will be maintained or adjusted to keep 30 to 60 mg*h ml-1. |
|
Evaluate the interaction between MMF or EC-MPS and the proton pump inhibitor omeprazole through the AUC in patients with MPA below target level (30mcg*h ml-1). |
| 6 months |
| Evaluate the association of MPA AUC with renal function estimated by MDRD formula. | Evaluate the association of MPA AUC with renal function estimated by MDRD formula. | Baseline; day one; months 2, 4 and 6. |
| Evaluate the MPA_AUC in renal transplant patients converted to mycophenolate sodium (MPS) with equivalent dose of mycophenolate mofetil (MMF). | Evaluate the MPA_AUC in renal transplant patients who were taking mycophenolate mofetil (MMF) and were converted to the use of mycophenolate sodium (MPS) by having the MPA concentration below the target level of 30 mcg*h ml-1. | Baseline, five days after day one, fourteen days after day one, months 2,4 and 6 |
| Evaluate the MPA_AUC in renal transplant patients maintained with mycophenolate mofetil (MMF). | Evaluate the AUC_MPA in renal transplant patients maintained with mycophenolate mofetil(MMF) by having the MPA concentration between 30-60 mcg*h ml-1 | baseline, months 2,4 and 6 |
| Study Director |
| Grinyo JM, Ekberg H, Mamelok RD, Oppenheimer F, Sanchez-Plumed J, Gentil MA, Hernandez D, Kuypers DR, Brunet M. The pharmacokinetics of mycophenolate mofetil in renal transplant recipients receiving standard-dose or low-dose cyclosporine, low-dose tacrolimus or low-dose sirolimus: the Symphony pharmacokinetic substudy. Nephrol Dial Transplant. 2009 Jul;24(7):2269-76. doi: 10.1093/ndt/gfp162. Epub 2009 Apr 8. |
| 20406219 | Background | Sommerer C, Muller-Krebs S, Schaier M, Glander P, Budde K, Schwenger V, Mikus G, Zeier M. Pharmacokinetic and pharmacodynamic analysis of enteric-coated mycophenolate sodium: limited sampling strategies and clinical outcome in renal transplant patients. Br J Clin Pharmacol. 2010 Apr;69(4):346-57. doi: 10.1111/j.1365-2125.2009.03612.x. |
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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