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MPA Pharmacokinetics in Renal Transplantation

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ClinicalTrials.gov Identifier: NCT01892761
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:
Adequate exposure to mycophenolic acid (MPA) is associated with better outcomes in kidney transplantation. This study evaluated repeated, MPA pharmacokinetics (MPA-PK) according to post-transplant time-points and concomitant CNIs. Fifty-two patients, 33 allocated to tacrolimus (TCL) and 19 to CyA (all with mycophenolate mofetil (MMF) and steroids), had the full MPA area under the time-concentration curve (AUC0-12hrs) repeatedly evaluated at days 7, 14, 30, 60 and 180 post-transplant. MMF daily dose was lower in TCL group as per protocol. Dose-adjusted MPA-AUC0-12hrs progressively increased throughout the study period in both groups but profiles were different according to the CNI regimen and time. The majority of patients were underexposed to MPA on day 7 for both groups what reinforces the need of a higher dose in the first week. Dose-adjusted MPA-AUC0-12hrs was higher in TCL group, after day 7, due to both a diminished MPA clearance (for both groups) and higher AUC4-12hrs in the TCL group. There was a progressive overexposure to MPA in order that at day 180, 21-30% of the patients were overexposed to MPA what indicates a time for MPA monitoring and dose correction for long-term follow-up. These PK data suggest that changes in MPA profile occur according to time and CNIs used and suggests that MPA monitoring may be mandatory at specific time-points.

Condition or disease Intervention/treatment
Kidney Transplantation Recipients Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups

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Study Type : Observational
Actual Enrollment : 52 participants
Time Perspective: Retrospective
Official Title: THE PROFILE OF MYCOPHENOLIC ACID IN CONSECUTIVE PHARMACOKINETICS AFTER RENAL TRANSPLANTATION:EFFECTS OF TIME AND CALCINEURIN-INHIBITORS
Study Start Date : September 2002
Actual Primary Completion Date : March 2003
Actual Study Completion Date : June 2005

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Group/Cohort Intervention/treatment
TCL/MMF Group Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups
CyA/MMF Group Drug: Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups



Primary Outcome Measures :
  1. To establish the dynamics of MPA-PK (AUC0-12hrs) during the first six months [ Time Frame: 6 months ]
    To establish the dynamics of MPA-PK during the first six months following transplantation according to time and the CNI regimen used in 52 patients who had their full MPA-PK monitored in 5 post-transplant time-points.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Renal transplant recipients
Criteria
Male and female patients aged 18-65 years, recipients of a non-HLA identical kidney allograft who presented a PRA < 50% were eligible for the MoDIFY trial. Subjects were excluded if they received a non-renal organ, had current history of alcohol or illicit drug abuse, had liver enzymes more than two times the upper normal limit or received induction with anti-lymphocyte preparations.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892761


Locations
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Brazil
Renal Transplantation Service
Sao Paulo, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Elias David-Neto, MD, PhD Renal Transplantation Service - Hospital das Clínicas - University of São Paulo School of Medicine, Sao Paulo, Brazil

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01892761     History of Changes
Other Study ID Numbers: CAPPesq 1013/02
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: June 2013
Keywords provided by University of Sao Paulo General Hospital:
mycophenolate mofetil
mycophenolic acid
MPA
MMF
Pharmacokinetics
renal transplantation
Additional relevant MeSH terms:
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Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action