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Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by IRCCS Policlinico S. Matteo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT00780429
First received: October 24, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00780429

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

No publications provided

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
Study First Received: October 24, 2008
Last Updated: October 24, 2008
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013