Advagraf/Prograf Conversion Trial

NCT01410162 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2015-09-01

No results posted yet for this study

Summary

Renal and kidney pancreas transplant patients will be randomized to once daily Advagraf or twice daily Prograf to assess changes in tacrolimus and mycophenolate mofetil exposure, renal allograft function, other relevant biochemical parameters and treatment related adverse effects.

Conditions

  • Renal Transplant
  • Kidney Pancreas Transplant

Interventions

DRUG

Tacrolimus

tacrolimus extended release capsules vs Prograf

Sponsors & Collaborators

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY
  • Norman Muirhead

    lead OTHER

Principal Investigators

  • Norman Muirhead · London Health Sciences Centre Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-02-28
Completion
2014-12-31

Countries

  • Canada

Study Locations

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Entities

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 NCT01410162 on ClinicalTrials.gov