NCT00121784

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_4

Geographic Reach
5 countries

28 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 21, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

July 15, 2005

Last Update Submit

November 1, 2016

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

  • Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n

Secondary Outcomes (1)

  • Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC\n

Study Arms (1)

1

EXPERIMENTAL

1

Drug: mycophenolate mofetil [CellCept]

Interventions

mycophenolate mofetil [CellCept]DRUG

1

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Maywood, Illinois, 60153, United States

Location

Unknown Facility

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Detroit, Michigan, 48202-2689, United States

Location

Unknown Facility

Minneapolis, Minnesota, 55455, United States

Location

Unknown Facility

Cleveland, Ohio, 44195, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19102, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Memphis, Tennessee, 38120, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Salt Lake City, Utah, 84148, United States

Location

Unknown Facility

Darlinghurst, 2010, Australia

Location

Unknown Facility

Perth, 6847, Australia

Location

Unknown Facility

Prahran, 3181, Australia

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Marseille, 13385, France

Location

Unknown Facility

Nantes, 44093, France

Location

Unknown Facility

Paris, 75651, France

Location

Unknown Facility

Paris, 75908, France

Location

Unknown Facility

Rennes, 35033, France

Location

Unknown Facility

Rouen, 76031, France

Location

Unknown Facility

Tours, 37044, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54511, France

Location

Unknown Facility

Berlin, 13353, Germany

Location

Unknown Facility

Hanover, 30625, Germany

Location

Unknown Facility

Heidelberg, 69120, Germany

Location

Unknown Facility

Jena, 07740, Germany

Location

Unknown Facility

Madrid, 28007, Spain

Location

Unknown Facility

Pamplona, 31008, Spain

Location

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2005

First Posted

July 21, 2005

Study Start

October 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

DE(4)ES(2)US(11)AU(3)FR(8)