NCT00780429

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
Last Updated

October 27, 2008

Status Verified

October 1, 2008

First QC Date

October 24, 2008

Last Update Submit

October 24, 2008

Conditions

Kidney Transplantation

Keywords

kidneytransplantMycophenolic acidInosine monophosphate dehydrogenase

Study Arms (3)

1

MMF+cyclosporine

2

MMF+tacrolimus

3

MMF+sirolimus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female renal transplant patients

You may qualify if:

  • Renal transplant recipients
  • Age range: 18-70
  • Patients taking MMF
  • Able to understand and sign an informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Fondazione Policlinico San Matteo

Pavia, 27100, Italy

Location

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

June 1, 2006

Last Updated

October 27, 2008

Record last verified: 2008-10

Locations

IT(1)