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Pilot Trial for Implementation of a MPA PK Monitoring Strategy

NCT00187915 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-10-20

No results posted yet for this study

Summary

This study is a prospective interventional trial of de novo renal transplant recipients, aiming to validate a strategy which combines the use of early post transplant MPA AUC sampling, and subsequent MPA trough level monitoring to implement MPA PK monitoring in a clinically applicable fashion.

Conditions

  • Transplant, Kidney

Interventions

DRUG

Mycophenolate mofetil + Tacrolimus

Target MPA exposure to 30-60 mg/L/h during first month post-transplant

DRUG

Mycophenolate mofetil + Cyclosporin

Target MPA exposure to 30-60 mg/L/h during first month post-transplant

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2004-11-30
Completion
2004-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00187915 on ClinicalTrials.gov