Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00170794
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus.

Condition or disease Intervention/treatment Phase
Cardiac Transplantation Drug: Everolimus (RAD001) Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A One Year, Multicenter, Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Cyclosporine Microemulsion in Cardiac Transplant Recipients.
Study Start Date : September 2004
Actual Primary Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Comparing calculated glomerular filtration rate (GFR) at Month 3 (Week 12) to Baseline and by comparing the daily cyclosporine dose at Month 3 (Week 12) to Baseline.

Secondary Outcome Measures :
  1. Incidence of acute rejection episode greater than or equal to grade 3A.
  2. Safety laboratory tests including lipid profiles, hematology and proteinuria.
  3. Incidence of premature study treatment discontinuation.
  4. Incidence of serious adverse avents (SAEs).
  5. Incidence of admission to the hospital.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Male or female cardiac transplant recipients, 18-70 years old, with established cardiac allograft vasculopathy or at risk to develop a cardiac allograft vasculopathy.
  • Patients who are more than 12 months post-transplant and who are receiving a cyclosporine microemulsion-based immunosuppressive regimen with/without azathioprine /mycophenolate mofetil, with/without steroids.
  • Patients need to have stable renal function with a calculated GFR exceeding 40 ml/min (Nankivell).
  • Patients without a biopsy-proven acute rejection ≥ grade 2, within 12 months prior to study entry.
  • Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Effective contraception must be used during the trial and for 4 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 from whom written informed consent has been obtained.

Exclusion Criteria:

  • Patients who are recipients of multiple solid organ transplants.
  • Patients with a calculated GFR of less than 40 ml/min.
  • Patients with a biopsy-proven acute rejection episode ≥ 2 within 12 months prior to study entry.
  • Patients who had received any investigational drug within 4 weeks prior to study entry.
  • Patients currently being treated with sirolimus or having a history of prior therapy or having a hypersensitivity to drug similar to everolimus.
  • Patient with a platelet count of < 50,000/mm3 or with a white blood cell count of ≤ 2,500/mm3 or with a hemoglobin value < 10 g/dL.
  • Presence of severe hypercholesterolemia (≥ 9.1 mmol/L) or hypertriglyceridemia (≥ 8.55 mmol/L).
  • Patient with NYHA class IV heart failure, or with left ventricular ejection fraction <30%. Patients with life-threatening cardiac allograft vasculopathy and/or graft dysfunction (life expectancy 1 year).
  • Patients with severe systemic infections.
  • Patients who are known to have HBsAg or HCV positive hepatitis, or who are HIV positive. Serology results obtained within 6 months prior to study entry are acceptable. If results cannot be obtained prior to study entry, a sample must be retained for later analysis. This stored sample will be destroyed at the end of study.
  • Patients with any past (within the last 5 years) or present malignancy other than non-melanotic skin cancer.
  • Existence of a co-morbid condition likely to result in death prior to study completion
  • Symptoms of significant mental illness, which in the opinion of the investigator may interfere with the patient's ability to comply with the protocol. History of drug or alcohol abuse within 1 year of baseline.
  • Inability to cooperate or communicate with the investigator.
  • Female patients of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00170794

Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Novartis

Additional Information:
Publications of Results:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00170794     History of Changes
Other Study ID Numbers: CRAD001A2412
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
cardiac transplantation, everolimus, cyclosporine microemulsion, GFR

Additional relevant MeSH terms:
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors