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

NCT ID: NCT00098007

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-09
• Study Completion Date: 2007-01-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Everolimus (Certican)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Cedar Sinai Medical Center

Los Angeles, California, United States

Tampa General Hospital

Tampa, Florida, United States

University of Minnesota

Minneapolis, Minnesota, United States

Newark Beth Israel Medical Center

Newark, New Jersey, United States

New York Presbyterian Medical Center

New York, New York, United States

Duke Clinical Research Institute

Durham, North Carolina, United States

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Texas Heart Institute/St Lukes Hospital

Houston, Texas, United States

The Baylor College of Medicine/ The Methodist Hospital

Houston, Texas, United States

St Luke's Medical Center

Milwaukee, Wisconsin, United States

Chermside, Queensland, Australia

Darlinghurst, , Australia

Innsbruck, , Austria

Vienna, , Austria

Belo Horizonte, Minas Gerais, Brazil

São Paulo, , Brazil

Vancouver, British Columbia, Canada

Toronto, Ontario, Canada

Hanover, , Germany

Kiel, , Germany

Milan, MI, Italy

Napoli, , Italy

A Coruña, , Spain

Barcelona, , Spain

Llobregat, , Spain

Oviedo, , Spain

Countries

United States; Australia; Austria; Brazil; Canada; Germany; Italy; Spain

References

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.

Reference Type: RESULT

PMID: 22295178 (View on PubMed)

Other Identifiers

RAD/Certican

Identifier Type: -

Identifier Source: secondary_id

CRAD001A2403

Identifier Type: -

Identifier Source: org_study_id