Pilot Trial for Implementation of a MPA PK Monitoring Strategy

University of Florida

Status: Completed

Conditions: Transplant, Kidney

Treatments: Drug: Mycophenolate mofetil + Tacrolimus; Drug: Mycophenolate mofetil + Cyclosporin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00187915

20030499 (Other Identifier)

CEL330

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

CellCept + Prograf

Other group

Description:

Standard of Care Regime

Treatment:

Drug: Mycophenolate mofetil + Tacrolimus

CellCept + Neoral

Other group

Description:

Standard of Care Regime

Treatment:

Drug: Mycophenolate mofetil + Cyclosporin