NCT01892761|Completed
MPA Pharmacokinetics in Renal Transplantation
THE PROFILE OF MYCOPHENOLIC ACID IN CONSECUTIVE PHARMACOKINETICS AFTER RENAL TRANSPLANTATION:EFFECTS OF TIME AND CALCINEURIN-INHIBITORS
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THE PROFILE OF MYCOPHENOLIC ACID IN CONSECUTIVE PHARMACOKINETICS AFTER RENAL TRANSPLANTATION:EFFECTS OF TIME AND CALCINEURIN-INHIBITORS
Sponsor study identifier
observational
52
1 country
1
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2003
Actual (reported)Study Completion
June 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2005
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
March 2003
Actual (reported)June 2005
Actual (reported)June 27, 2013
Actual (reported)July 4, 2013
Actual (reported)To establish the dynamics of MPA-PK (AUC0-12hrs) during the first six 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.
6 months
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Renal transplant recipients
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Renal Transplantation Service
São Paulo, São Paulo, 05403-900, Brazil
Elias David-Neto, MD, PhD
Renal Transplantation Service - Hospital das Clínicas - University of São Paulo School of Medicine, Sao Paulo, Brazil
52 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2013
First Posted
July 4, 2013
Study Start
September 2002
Date type not reportedThis date has not been verified as actual or estimated.
Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%
Primary Completion
March 2003
Actual (reported)Study Completion
June 2005
Actual (reported)Last Updated
July 4, 2013
Record last verified: 2013-06
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Source: ClinicalTrials.gov.
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