Pilot Trial for Implementation of a MPA PK Monitoring Strategy

Study Overview
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Brief Summary
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This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.

Detailed Description
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Mycophenolate mofetil or MMF (CellCept® by Roche) is the mofetil ester of mycophenolic acid (MPA), the active immunosuppressant. 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.

Official Title
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Pilot Trial for Implementation of a MPA PK Monitoring Strategy

Conditions
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Transplant, Kidney

Intervention / Treatment
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* Drug: Mycophenolate mofetil + Tacrolimus
* Drug: Mycophenolate mofetil + Cyclosporin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary or secondary cadaveric or living donor kidney recipients On Cellcept Exclusion Criteria: Multi organ recipients 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CellCept + Prograf<br>Standard of Care Regime | Drug: Mycophenolate mofetil + Tacrolimus<br>* Target MPA exposure to 30-60 mg/L/h during first month post-transplant<br>* Other names: Prograf;|
| Other: CellCept + Neoral<br>Standard of Care Regime | Drug: Mycophenolate mofetil + Cyclosporin<br>* Target MPA exposure to 30-60 mg/L/h during first month post-transplant<br>* Other names: Neoral;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with an average AUC between 30-60 ng x hr/mL |  | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of acute rejection of transplanted kidney |  | 7 months | 
| Number of MPA related toxicities |  | 7 months | 
| Number of dose changes required to obtain MPA AUC target in the first month |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplant, Cellcept, Therapeutic drug level, Mycophenolate mofetil (MMF), Mycophenolate Acid (MPA), Oral Bioavailability, Immunosuppression