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Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

NCT00885820 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2014-09-18

No results posted yet for this study

Summary

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

Conditions

  • Kidney Transplantation

Interventions

DRUG

Tacrolimus

Oral

DRUG

MMF

Oral

DRUG

Corticosteroids (Prednisone)

Oral

Sponsors & Collaborators

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Use Central Contact · Astellas Pharma Canada, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-09-30
Primary Completion
2004-07-31
Completion
2006-01-31

Countries

  • United States
  • 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 NCT00885820 on ClinicalTrials.gov