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

NCT00098007 | Completed Phase 3

• 2 other identifiers: CRAD001A2403RAD/Certican
• Study Type: interventional
• Target: 199
• Locations: 7 countries
• Sites: 26

Brief Summary

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.

Conditions

Heart Transplantation

Keywords

Heart transplantation; Everolimus; De novo heart transplant patients

Outcome Measures

Primary Outcomes (1)

• Renal function at 6 months post-transplant.

Secondary Outcomes (5)

• 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.

Interventions

Everolimus (Certican) DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

The University of Alabama at Birmingham

Birmingham, Alabama, 35294-0006, United States

Location

Cedar Sinai Medical Center

Los Angeles, California, 900048, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07102, United States

Location

New York Presbyterian Medical Center

New York, New York, 10032, United States

Location

Duke Clinical Research Institute

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Texas Heart Institute/St Lukes Hospital

Houston, Texas, 77030, United States

Location

The Baylor College of Medicine/ The Methodist Hospital

Houston, Texas, 77030, United States

Location

St Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Unknown Facility

Chermside, Queensland, 4032, Australia

Location

Unknown Facility

Darlinghurst, NSW2010, Australia

Location

Unknown Facility

Innsbruck, 6020, Austria

Location

Unknown Facility

Vienna, 1090, Austria

Location

Unknown Facility

Belo Horizonte, Minas Gerais, Brazil

Location

Unknown Facility

São Paulo, 05403-000, Brazil

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2C4, Canada

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Kiel, 24105, Germany

Location

Unknown Facility

Milan, MI, 20162, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

A Coruña, 15006, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Llobregat, 08907, Spain

Location

Unknown Facility

Oviedo, 33006, Spain

Location

Related Publications (1)

• 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.

  PMID: 22295178 RESULT

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Design

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

Study Record Dates

• First Submitted: December 1, 2004
• First Posted: December 2, 2004
• Study Start: August 9, 2004
• Primary Completion: January 8, 2007
• Study Completion: January 8, 2007
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

ES (4); IT (2); DE (2); US (12); CA (2); AU (2); BR (2)