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A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)

NCT01822483 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-04-03

No results posted yet for this study

Summary

The purpose of this study is investigate mycophenolic acid exposure through area under the curve in renal transplants recipients treated with mycophenolate mofetil and after conversion to mycophenolate sodium.

Conditions

  • Renal Transplantation

Interventions

DRUG

Mycophenolate sodium

The conversion will be performed abruptly for all patients. Mycophenolate mofetil will be discontinued one day before the day of conversion (Day 1). Mycophenolate sodium will be introduced on day 1 with equivalent doses.

DRUG

Mycophenolate mofetil

Mycophenolate mofetil dose will be maintained or adjusted to keep 30 to 60 mg\*h ml-1.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Irmandade Santa Casa de Misericórdia de Porto Alegre

    lead OTHER

Principal Investigators

  • Valter Garcia, Physician · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • Elizete Keitel, Physician · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • Daniela Seelig, Physician · IRMANDADE DA SANTA CASA DE MISERICÓRIDA DE PORTO ALEGRE

  • Fabiano Klaus, Physician · IRMANDADE DA SANTA CASA DE MISERICÓRIDA DE PORTO ALEGRE

  • Ronivan Dal Pra, Pharmacist · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • Larissa Pacheco, Pharmacist · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • Bruna Cardoso, Pharmacist · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • Roger Kist, Trainee · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • Helen Zanetti, Pharmacist · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Brazil

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 NCT01822483 on ClinicalTrials.gov