Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2010-02-28

Brief Summary

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This study investigated whether initiation of everolimus together with reduction of calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal impairment would improve renal function.

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Detailed Description

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Conditions

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Disorder Related to Cardiac Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Everolimus + CNI reduction

Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level \< 75 ng/mL or a tacrolimus trough level \< 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice.

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.

Calcineurin inhibitors (CNI)

Intervention Type DRUG

Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.

Steroids

Intervention Type DRUG

Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.

Control

CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.

Group Type ACTIVE_COMPARATOR

Mycophenolic acid (MPA)/azathioprine (AZA)

Intervention Type DRUG

In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.

Calcineurin inhibitors (CNI)

Intervention Type DRUG

Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.

Steroids

Intervention Type DRUG

Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.

Interventions

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Everolimus

0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.

Intervention Type DRUG

Mycophenolic acid (MPA)/azathioprine (AZA)

In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.

Intervention Type DRUG

Calcineurin inhibitors (CNI)

Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.

Intervention Type DRUG

Steroids

Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.

Intervention Type DRUG

Other Intervention Names

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Certican Neoral®/Prograf®

Eligibility Criteria

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Inclusion Criteria

* Patients who have undergone a heart or lung transplantation more than 12 months ago.
* Patients receiving Neoral® or Prograf®.
* Patients with a measured or calculated glomerular filtration rate (GFR) \> 20 and \< 70 mL/min/1.73m\^2. For patients with a GFR \> 60 and \< 70 mL/min/1.73m\^2, a deteriorated renal function since the time of transplantation must be documented by at least one post-transplant GFR level that is \> 10% above the GFR level at the time of inclusion.
* Patients willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months.
* 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.

Exclusion Criteria

* Patients who are recipients of multiple organ transplants.
* Patients with measured GFR \< 20 mL/min/1.73m\^2 or \> 70 mL/min/1.73m\^2.
* Patients with a treated acute rejection episode within the last 3 months.
* Patients with a platelet count of \< 50,000/mm\^3 or with a white blood cell count of ≤ 2,500/mm\^3 or with a hemoglobin value \< 8 g/dL.
* Presence of severe hypercholesterolemia (≥ 8.0 mmol/L) or hypertriglyceridemia (≥ 6.0 mmol/L) despite conventional lipid lowering treatment.
* Patients currently treated or who have been treated with a mammalian target of rapamycin (mTOR) inhibitor.
* Patients who have received an investigational drug within 4 weeks.
* Patients who are human immunodeficiency virus positive or who have a current severe systemic infection requiring continued therapy according to investigator judgment.
* Present use of any immunosuppressive drugs other than Neoral®/Prograf®, mycophenolic acid/azathioprine (MPA/AZA), and/or steroids.
* Patients with a known hypersensitivity to drugs similar to everolimus.
* 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.
* Patients with any past (within the last 5 years) or present malignancy other than excised squamous or basal cell carcinoma.
* Females of childbearing potential that are planning to become pregnant, who are pregnant and/or lactating, or who are unwilling to use effective means of contraception.
* Patients with a planned coronary revascularization or patients who have experienced a major adverse cardiovascular event (MACE) within the last 3 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No