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Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

NCT ID: NCT00780429

Last Updated: 2008-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplantation

Keywords

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kidney transplant Mycophenolic acid Inosine monophosphate dehydrogenase

Study Groups

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1

MMF+cyclosporine

No interventions assigned to this group

2

MMF+tacrolimus

No interventions assigned to this group

3

MMF+sirolimus

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role lead

Responsible Party

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IRCCS Fondazione Policlinico San Matteo

Locations

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IRCCS Fondazione Policlinico San Matteo

Pavia, , Italy

Site Status

Countries

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Italy

Other Identifiers

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06/2006/REVO

Identifier Type: -

Identifier Source: org_study_id