NCT00150046

Brief Summary

This study will test the safety and efficacy of everolimus on heart transplant recipients. This study is not recruiting in the United States.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

February 11, 2020

Status Verified

November 1, 2011

Enrollment Period

2.4 years

First QC Date

August 26, 2005

Last Update Submit

February 8, 2020

Conditions

Heart Transplantation

Keywords

Heart transplantationEverolimusHeart transplant recipient

Outcome Measures

Primary Outcomes (1)

  • compare renal function

Secondary Outcomes (1)

  • compare rates of acute rejection, efficacy and safety

Interventions

EverolimusDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigational Site

Germany, Germany

Location

Basel Novartis Pharma AG

Basel, Switzerland

Location

Related Publications (2)

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

    RESULT

  • Vigano M, Dengler T, Mattei MF, Poncelet A, Vanhaecke J, Vermes E, Kleinloog R, Li Y, Gezahegen Y, Delgado JF; RAD A2411 Study Investigators. Lower incidence of cytomegalovirus infection with everolimus versus mycophenolate mofetil in de novo cardiac transplant recipients: a randomized, multicenter study. Transpl Infect Dis. 2010 Feb;12(1):23-30. doi: 10.1111/j.1399-3062.2009.00448.x. Epub 2009 Sep 9.

    PMID: 19744284DERIVED

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Basel Novartis Pharma AG

    Basel Novartis Pharma AG

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2005

First Posted

September 8, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2007

Last Updated

February 11, 2020

Record last verified: 2011-11

Locations

CH(1)DE(1)