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Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

Sponsor
IRCCS Policlinico S. Matteo (Other)
Overall Status
Unknown status
CT.gov ID
NCT00780429
Collaborator
(none)
54
Enrollment
1
Location

Study Details

Study Description

Brief Summary

Study of the pharmacokinetic and pharmacodynamic variability of mycophenolate mofetil in renal transplant patients already on long-term MMF treatment (at least 6 months post-transplant; at least 3 months in therapy).

Study hypothesis: to investigate whether long-term MMF therapy alters IMPDH biological activity and if there are any correlations with the risk of AR.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Official Title:
    Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months
    Study Start Date :
    Jun 1, 2006

    Arms and Interventions

    Arm Intervention/Treatment
    1

    MMF+cyclosporine
    2

    MMF+tacrolimus
    3

    MMF+sirolimus

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:

      • Renal transplant recipients

      • Age range: 18-70

      • Patients taking MMF

      • Able to understand and sign an informed consent

      Exclusion Criteria:

      • Active myelodepression

      • Systemic infections or other that may affect MMF absorption

      • Pregnancy/breastfeeding

      • (History of) cancer

      • Drug abuse, psychiatric conditions

      • Already enrolled in other clinical trials or participation ended less than one month earlier

      • Known sensitivity to polysorbate 80 or MMF

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 IRCCS Fondazione Policlinico San Matteo Pavia Italy 27100

      Sponsors and Collaborators

      • IRCCS Policlinico S. Matteo

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00780429
      Other Study ID Numbers:
      • 06/2006/REVO
      First Posted:
      Oct 27, 2008
      Last Update Posted:
      Oct 27, 2008
      Last Verified:
      Oct 1, 2008
      Keywords provided by , ,
      kidney
      transplant
      Mycophenolic acid
      Inosine monophosphate dehydrogenase

      Study Results

      No Results Posted as of Oct 27, 2008