- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00098007
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
Six-month, Multicenter, Randomized, Open-label Study of the Safety, Tolerability and Efficacy of Two Neoral Doses in Addition to Certican and Steroids in de Novo Heart Transplant Recipients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Darlinghurst, Australia, NSW2010
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Queensland
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Chermside, Queensland, Australia, 4032
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Innsbruck, Austria, 6020
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Vienna, Austria, 1090
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Sao Paulo, Brazil, 05403-000
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MG
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Belo Horizonte, MG, Brazil
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British Columbia
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Vancouver, British Columbia, Canada
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
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Hannover, Germany
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Kiel, Germany, 24105
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Napoli, Italy, 80131
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MI
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Milano, MI, Italy, 20162
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Barcelona, Spain, 08036
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La Coruna, Spain, 15006
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Llobregat, Spain, 08907
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Oviedo, Spain, 33006
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Alabama
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Birmingham, Alabama, United States, 35294-0006
- The University of Alabama at Birmingham
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California
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Los Angeles, California, United States, 900048
- Cedar Sinai Medical Center
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Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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New Jersey
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Newark, New Jersey, United States, 07102
- Newark Beth Israel Medical Center
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New York
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New York, New York, United States, 10032
- New York Presbyterian Medical Center
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Clinical Research Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19140
- Temple University Hospital
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Medical Center
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Texas
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Houston, Texas, United States, 77030
- Texas Heart Institute/St Lukes Hospital
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Houston, Texas, United States, 77030
- The Baylor College of Medicine/ The Methodist Hospital
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Wisconsin
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Milwaukee, Wisconsin, United States, 53215
- St Luke's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria Male or female cardiac patients 18-65 years old undergoing primary heart transplantation.
Females of potential childbearing age must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication, even where there has been a history of infertility.
Patients who are willing and able to participate in the full course of the study and for whom written informed consent has been obtained.
Exclusion criteria Patients with donor hearts greater than 60 years of age and/or with a cold ischemia time of more than 6 hours and/or donor hearts which have obvious coronary disease or are known to have heart disease at time of transplant.
Patients who are recipients of multiple solid organ transplants, or who are previously received transplanted organs.
Patients who had received any investigational drug or who have been treated with an immunosuppressive drug treatment within 4 weeks prior to study entry.
Patients with serum creatinine level > 250 mol/L. Patients with platelet count ≤ 50,000/mm3 or with a white blood cell count of ≤ 2,500/mm3.
Patients with active systemic infection, according to the investigator judgment, requiring continued therapy.
Patients with a known hypersensitivity to mTOR inhibitors. Patients with Panel Reactive Antibodies ≥ 25%. Presence of severe hypercholesterolemia (≥ 350mg/dL;≥9 mmol/L) or hypertriglyceridemia (≥ 750 mg/dL; ≥ 8.5 mmol/L).
Presence of any severe allergy requiring acute (within 4 weeks of baseline) or chronic treatment, or hypersensitivity to drugs similar to Certican (e.g., macrolides).
Symptoms of a significant mental illness, which is in the opinion of the investigator may interfere with the patients ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
Patients with any past (within the last 5 years) or present malignancy other than excised squamous or basal cell carcinoma.
Patients with any history of significant coagulopathy or medical condition requiring long-term anticoagulation after transplantation (low dose of aspirin treatment is allowed).
Abnormal physical or laboratory findings of clinical significance within 2 weeks prior to study entry which would interfere with the objectives of the study.
Inability to cooperate or communicate with the investigator. Female of childbearing potential to who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
Breast feeding women. Patients who are recipients of A-B-O incompatible transplants. Patients who are known to have chronic active Hepatitis C (PCR+ only), who are HIV or Hepatitis B surface antigen positive. Laboratory results obtained within 6 months prior to randomization are acceptable.
Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Renal function at 6 months post-transplant.
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Secondary Outcome Measures
Outcome Measure |
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Incidence of biopsy proven acute rejection ≥3A at 6 months.
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Incidence of acute rejection associated with hemodynamic compromise at 6 months.
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Incidence of graft loss at 6 months.
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Incidence of death at 6 months.
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Incidence of premature patient withdrawal and study treatment discontinuation at 6 months.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRAD001A2403
- RAD/Certican
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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