Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00150046
First received: August 26, 2005
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

This study will test the safety and efficacy of everolimus on heart transplant recipients.

This study is not recruiting in the United States.


Condition Intervention Phase
Heart Transplantation
Drug: Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A 12-month, Multicenter, Randomized, Open-label Non-inferiority Study of Renal Function and Efficacy Comparing Concentration-controlled Certican (1.5 mg/Day Starting Dose) With Reduced Neoral Dose Versus MMF With Standard Neoral Dose in de Novo Heart Transplant Recipients

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • compare renal function

Secondary Outcome Measures:
  • compare rates of acute rejection, efficacy and safety

Estimated Enrollment: 176
Study Start Date: December 2004
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Male or female cardiac recipients 18-65 years of age undergoing primary heart transplantation. The graft must be functional at the time of randomization.
  • Calculated creatinine clearance (Cockroft-Gault) ≥ 50 mL/min at screening.
  • Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

Patients who are recipients of multiple solid organ transplants or have previously received organ transplants.

Patients who received any investigational drug or who have been treated with an immunosuppressive drug or treatment within 1 month prior to randomization Patients receiving induction therapy which is not standard per local practice Patients with donor greater than 60 years and/or with known donor coronary or heart disease at the time of transplant.

Donor heart cold ischemic time >6 hours. Patients with Panel Reactive Antibodies >20%. Patients who are recipients of ABO incompatible transplants Patients with platelet count <50,000/mm3 at the evaluation before randomization.

Presence of severe hypercholesterolemia (≥350 mg/dL; ≥9 mmol/L) or hypertriglyceridemia (≥750 mg/dL; ≥8.5 mmol/L) Patients with an absolute neutrophil count of ≤1,500/mm3 or white blood cell count of ≤4000/mm3 at baseline before surgery Patients with a history of significant coagulopathy or medical condition requiring long term anti-coagulation after transplantation (low dose aspirin treatment is allowed) Patients who are HIV-positive or Hepatitis C (PCR+ only) or B surface antigen positive. Laboratory results obtained within 6 months prior to study entry are acceptable.

Recipients of organs from donors who test positive for Hepatitis B surface antigen or Hepatitis C (PCR+ only) are excluded Patients with a known hypersensitivity to similar drugs and to the components of the formulations Patients being treated with terfenadine, astemizole, or cisapride. Patients who are treated with drugs strong inducers or inhibitors of cytochrome P450 3A4.

Patients with any past (within the past 5 years) or present malignancy (other than excised basal cell carcinoma) Patients with clinically significant systemic infection Patients who are unable to take oral medication Existence of any surgical or medical condition, which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism and excretion of study medication, and/or the presence of severe diarrhea or active peptic ulcer Abnormal physical or laboratory findings of clinical significance within 2 weeks of randomization which would interfere with the objectives of the study Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception

  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: NCT00150046

Locations
Germany
Novartis Investigational Site
Germany, Germany
Switzerland
Basel Novartis Pharma AG
Basel, Switzerland
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: Basel Novartis Pharma AG Basel Novartis Pharma AG
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00150046     History of Changes
Other Study ID Numbers: CRAD001A2411
Study First Received: August 26, 2005
Last Updated: November 1, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
Heart transplantation
Everolimus
Heart transplant recipient

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

ClinicalTrials.gov processed this record on August 27, 2014