A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients

Phase 3

Completed

• Conditions: Heart Transplantation

• Registration Number: NCT00098007
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy.

This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-09
• Study First Submitted: 2004-12-01
• Study First Submitted QC: 2004-12-01
• Study First Posted: 2004-12-02
• Primary Completion: 2007-01-08
• Study Completion: 2007-01-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-20
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Renal function at 6 months post-transplant.

Secondary Outcome Measures

Name	Time	Method
Incidence of graft loss at 6 months.
Incidence of death at 6 months.
Incidence of acute rejection associated with hemodynamic compromise at 6 months.
Incidence of biopsy proven acute rejection ≥3A at 6 months.
Incidence of premature patient withdrawal and study treatment discontinuation at 6 months.

Trial Locations

Locations (12)

Cedar Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Newark Beth Israel Medical Center; 🇺🇸 Newark, New Jersey, United States

University of Pennsylvania Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Texas Heart Institute/St Lukes Hospital; 🇺🇸 Houston, Texas, United States

The Baylor College of Medicine/ The Methodist Hospital; 🇺🇸 Houston, Texas, United States

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States

The University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

St Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States

New York Presbyterian Medical Center; 🇺🇸 New York, New York, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States