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Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

NCT00299221 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-05-28

Study results available
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Summary

This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.

Conditions

  • Immunosuppression

Interventions

DRUG

Tacrolimus

tacrolimus

DRUG

combination therapy

MMF

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Newark Beth Israel Medical Center

    lead OTHER

Principal Investigators

  • David A Baran, MD · Newark Beth Israel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2009-06-30
Completion
2009-12-31

Countries

  • United States

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 NCT00299221 on ClinicalTrials.gov