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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00098007
First received: December 1, 2004
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Heart Transplantation
Drug: Everolimus (Certican)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Renal function at 6 months post-transplant.

Secondary Outcome Measures:
  • 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.

Enrollment: 199
Study Start Date: August 2004
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098007

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0006
United States, California
Cedar Sinai Medical Center
Los Angeles, California, United States, 900048
United States, Florida
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07102
United States, New York
New York Presbyterian Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The Baylor College of Medicine/ The Methodist Hospital
Houston, Texas, United States, 77030
Texas Heart Institute/St Lukes Hospital
Houston, Texas, United States, 77030
United States, Wisconsin
St Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Australia, Queensland
Chermside, Queensland, Australia, 4032
Australia
Darlinghurst, Australia, NSW2010
Austria
Innsbruck, Austria, 6020
Vienna, Austria, 1090
Brazil
Belo Horizonte, MG, Brazil
Sao Paulo, Brazil, 05403-000
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada, M5G 2C4
Germany
Hannover, Germany
Kiel, Germany, 24105
Italy
Milano, MI, Italy, 20162
Napoli, Italy, 80131
Spain
Barcelona, Spain, 08036
La Coruna, Spain, 15006
Llobregat, Spain, 08907
Oviedo, Spain, 33006
Sponsors and Collaborators
Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00098007     History of Changes
Other Study ID Numbers: CRAD001A2403, RAD/Certican
Study First Received: December 1, 2004
Last Updated: November 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Heart transplantation
Everolimus
De novo heart transplant patients

Additional relevant MeSH terms:
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014