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Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by IRCCS Policlinico S. Matteo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00780429
First Posted: October 27, 2008
Last Update Posted: October 27, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
IRCCS Policlinico S. Matteo
  Purpose

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
Kidney Transplantation

Study Type: Observational
Official Title: Evaluation of Pharmacokinetic and Pharmacodynamic Parameters in Renal Transplant Patients Receiving Mycophenolic Acid and Stable for at Least 3 Months

Resource links provided by NLM:


Further study details as provided by IRCCS Policlinico S. Matteo:

Enrollment: 54
Study Start Date: June 2006
Groups/Cohorts
1
MMF+cyclosporine
2
MMF+tacrolimus
3
MMF+sirolimus

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male and female renal transplant patients
Criteria

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
Information from the National Library of Medicine

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): NCT00780429


Locations
Italy
IRCCS Fondazione Policlinico San Matteo
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
  More Information

Responsible Party: Prof. Antonio Dal Canton, IRCCS Fondazione Policlinico San Matteo
ClinicalTrials.gov Identifier: NCT00780429     History of Changes
Other Study ID Numbers: 06/2006/REVO
First Submitted: October 24, 2008
First Posted: October 27, 2008
Last Update Posted: October 27, 2008
Last Verified: October 2008

Keywords provided by IRCCS Policlinico S. Matteo:
kidney
transplant
Mycophenolic acid
Inosine monophosphate dehydrogenase

Additional relevant MeSH terms:
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action