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Effect of Switching to Certican® in Viremia of Hepatitis C Virus in Adult Renal Allograft Recipients

NCT01469884 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-03

No results posted yet for this study

Summary

Compare the viral load of hepatitis c virus in patients converted to certican versus patients who are maintained on calcineurin inhibitor.

Conditions

  • Renal Allograft
  • Hepatitis C

Interventions

DRUG

Everolimus

The conversion will be performed abruptly for all patients. Calcineurin inhibitor will be discontinued one day before the day of conversion (Day 1). Everolimus will be introduced on day 1 at dose of 3 mg/d (1,5mg bid), and then everolimus trough levels will be adjusted to achieve 6-10 ng/ml.

DRUG

Cyclosporine

Trough level should be between 100 and 200ng/ml.

DRUG

Tacrolimus

Trough level should be between 5 and 10ng/ml.

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

  • MARIANA F RODRIGUES, PHARMACIST · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • DIEGO GNATTA, PHARMACIST · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • LARISSA S PACHECO, PHARMACIST · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • BRUNA D CARDOSO, PHARMACIST · IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE

  • RONIVAN L DAL PRA, 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
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 NCT01469884 on ClinicalTrials.gov