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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098007
Recruitment Status : Completed
First Posted : December 2, 2004
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

December 1, 2004
December 2, 2004
February 23, 2017
August 9, 2004
January 8, 2007   (Final data collection date for primary outcome measure)
Renal function at 6 months post-transplant.
  • To determine whether Neoral dose optimization can improve renal function in de novo heart recipients receiving Neoral in addition to Everolimus
  • This will be assessed by comparing renal function post-transplant between 2 groups of patients.
Complete list of historical versions of study NCT00098007 on Archive Site
  • Incidence of biopsy proven acute rejection ≥3A at 6 months.
  • Incidence of acute rejection associated with hemodynamic compromise at 6 months.
  • Incidence of graft loss at 6 months.
  • Incidence of death at 6 months.
  • Incidence of premature patient withdrawal and study treatment discontinuation at 6 months.
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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.

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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Heart Transplantation
Drug: Everolimus (Certican)
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Zuckermann A, Wang SS, Ross H, Frigerio M, Eisen HJ, Bara C, Hoefer D, Cotrufo M, Dong G, Junge G, Keogh AM. Efficacy and Safety of Low-Dose Cyclosporine with Everolimus and Steroids in de novo Heart Transplant Patients: A Multicentre, Randomized Trial. J Transplant. 2011;2011:535983. doi: 10.1155/2011/535983. Epub 2011 Sep 13.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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January 8, 2007
January 8, 2007   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Brazil,   Canada,   Germany,   Italy,   Spain,   United States
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP