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NCT00780429 Clinical Trial

Pharmacokinetics and Pharmacodynamics of MPA in Stable Renal Transplant Patients

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00780429
Other study ID # 06/2006/REVO
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 24, 2008
Last updated October 24, 2008
Start date June 2006

Study information
Verified date October 2008
Source IRCCS Policlinico S. Matteo
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 54
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS Fondazione Policlinico San Matteo Pavia

Sponsors (1)
Lead Sponsor Collaborator
IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

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