Efficacy and Safety of Everolimus in de Novo Heart Transplant Recipients

Heart Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150046
• Other study ID #: CRAD001A2411
• Status: Completed
• Phase: Phase 3
• Start date: December 2004

Study information

• Verified date: November 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

This study is not recruiting in the United States.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. primary completion date: May 2007
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Drug:
• Everolimus

Locations

Country	Name	City	State
Germany	Novartis Investigational Site	Germany
Switzerland	Basel Novartis Pharma AG	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Lehmkuhl et al., Transplantation, Volume 88, Number 1, July 15, 2009

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare renal function
Secondary	compare rates of acute rejection, efficacy and safety