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Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts

NCT00933231 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 281

Last updated 2024-11-01

No results posted yet for this study

Summary

This is a multicentre study examining the use of Advagraf-minimization strategy and/or the use of an inhibitor of the renin-angiotensin system in reducing chronic rejection in renal allografts.

Conditions

  • Kidney Transplantation

Interventions

DRUG

tacrolimus

Standard dose, Oral

DRUG

tacrolimus

Low dose, Oral

BIOLOGICAL

Simulect

IV

DRUG

Cellcept

Oral

DRUG

Corticosteroids

IV and Oral

DRUG

Ramipril

Oral

DRUG

Irbesartan

Oral

Sponsors & Collaborators

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Principal Investigator · University of Alberta

  • Use Central Contact · Astellas Pharma Canada, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-17
Primary Completion
2015-05-11
Completion
2018-04-03

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00933231 on ClinicalTrials.gov