Status:
COMPLETED
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 9 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2007
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00098007
Start Date
August 9 2004
End Date
January 8 2007
Last Update
February 23 2017
Active Locations (28)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
2
Cedar Sinai Medical Center
Los Angeles, California, United States, 900048
3
Tampa General Hospital
Tampa, Florida, United States, 33606
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455