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MPA PK Monitoring Strategy With MMF/FK Based Immunosuppression

NCT00187941 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2012-06-20

No results posted yet for this study

Summary

Individuals absorb Cellcept (MMF/Mycophenolate Mofetil) at different rates and it is difficult to determine an individuals level of Mycophenolate Mofetil (MMF, trade name Cellcept)from a single measurement. We will enroll 20 subjects. Plasma samples to be collected pre-MMF dose (trough level) and at 30 and 120 min after the morning dose of MMF.This will be done weekly for the first month and then monthly for the next 6 mths. We hope to use a calculation of the subjects total MMF level during the first month to set a trough target level to use during the next 6 months.

Conditions

  • Transplantation, Renal
  • Immunosuppression

Interventions

DRUG

Mycophenolate Mofetil

Targeted MPA exposure to 30-60 mg/L/h during the first month post-transplant.

Sponsors & Collaborators

Principal Investigators

  • Herwig-Ulf Meier-Kriesche, MD · University of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00187941 on ClinicalTrials.gov