Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients

NCT ID: NCT00121784

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-08-31

Brief Summary

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Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.

Detailed Description

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Conditions

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Heart Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

1

Group Type EXPERIMENTAL

mycophenolate mofetil [CellCept]

Intervention Type DRUG

1

Interventions

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mycophenolate mofetil [CellCept]

1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult (\>=18 years of age) heart transplant patients (4-6 weeks post-transplant);
* receipt of first heart (single-organ) transplant;
* standard care regimen of CNI, MMF, and corticosteroids since transplantation.

Exclusion Criteria

* positive donor-specific cross-match at time of transplantation;
* history of malignancies, other than non-melanoma skin cancer that has been totally excised with no recurrence for 2 years;
* patients participating in another interventional clinical trial or requiring treatment with unmarketed investigational drugs.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

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Chicago, Illinois, United States

Site Status

Maywood, Illinois, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Salt Lake City, Utah, United States

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Darlinghurst, , Australia

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Perth, , Australia

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Prahran, , Australia

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Innsbruck, , Austria

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Marseille, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Rennes, , France

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Rouen, , France

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Tours, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Jena, , Germany

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Madrid, , Spain

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Pamplona, , Spain

Site Status

Countries

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Belgium Canada China Czechia United Kingdom United States Australia Austria France Germany Spain

Other Identifiers

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MT18328

Identifier Type: -

Identifier Source: org_study_id