Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

This study is ongoing, but not recruiting participants.

First Received: October 24, 2008 No Changes Posted

Sponsored by:	IRCCS Policlinico S. Matteo
Information provided by:	IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:	NCT00780429

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:

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Mycophenolic acid

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:	IRCCS Fondazione Policlinico San Matteo ( Prof. Antonio Dal Canton )
Study ID Numbers:	06/2006/REVO
Study First Received:	October 24, 2008
Last Updated:	October 24, 2008
ClinicalTrials.gov Identifier:	NCT00780429 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by IRCCS Policlinico S. Matteo:

kidney
transplant
Mycophenolic acid
Inosine monophosphate dehydrogenase

Study placed in the following topic categories:

Anti-Bacterial Agents
Mycophenolic Acid

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mycophenolic Acid

Enzyme Inhibitors
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 01, 2009