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Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

NCT00377962 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2020-07-30

Study results available
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Summary

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.

Conditions

  • Disorder Related to Cardiac Transplantation

Interventions

DRUG

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.

DRUG

Mycophenolic acid (MPA)/azathioprine (AZA)

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

DRUG

Calcineurin inhibitors (CNI)

Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Denmark
  • Norway
  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00377962 on ClinicalTrials.gov