- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01276457
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients (EVEREST)
May 17, 2011 updated by: Novartis Pharmaceuticals
An 18 Month Extension to the Multicenter, Randomized, Open-label Trial (NCT00170885) to Evaluate the Safety, Tolerability, and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
223
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with functioning graft who had completed the 6-month treatment period of core study
- Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study
- Patients who signed the informed consent of the present study extension
Exclusion Criteria:
- Women who were pregnant, lactating or who wished to became pregnant.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Upper everolimus blood target + very low dose cyclosporine
Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL.
Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose.
Both drugs were taken in the morning and again 12 hours later.
The drugs were taken consistently either before, during, or after meals.
No grapefruit or grapefruit juice was allowed throughout the study.
|
The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range.
Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.
The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level.
Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
Other Names:
|
ACTIVE_COMPARATOR: Standard everolimus blood target + low dose cyclosporine
Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL.
Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose.
Both drugs were taken in the morning and again 12 hours later.
The drugs were taken consistently either before, during, or after meals.
No grapefruit or grapefruit juice was allowed throughout the study.
|
The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range.
Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.
The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level.
Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Biopsy-proven Acute Rejection
Time Frame: Baseline to end of study (Month 24)
|
A graft core biopsy was performed on all suspected acute rejection episodes within 48 hours.
Biopsies were read by the local pathologist according to the 1997 Banff criteria.
A biopsy-proven acute rejection was be defined as a biopsy graded IA, IB, IIA, IIB, or III.
|
Baseline to end of study (Month 24)
|
Renal Function Assessed by Creatinine Clearance
Time Frame: Month 12, Month 18, and Month 24
|
Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.
|
Month 12, Month 18, and Month 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft
Time Frame: Baseline to end of study (Month 24)
|
A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.
|
Baseline to end of study (Month 24)
|
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths
Time Frame: Baseline to end of study (Month 24)
|
Safety was assessed using reports of adverse events of all participants in this study.
Serious adverse events are those events that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
|
Baseline to end of study (Month 24)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (ACTUAL)
February 1, 2009
Study Completion (ACTUAL)
February 1, 2009
Study Registration Dates
First Submitted
January 12, 2011
First Submitted That Met QC Criteria
January 12, 2011
First Posted (ESTIMATE)
January 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 20, 2011
Last Update Submitted That Met QC Criteria
May 17, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Antifungal Agents
- Calcineurin Inhibitors
- Everolimus
- Cyclosporine
- Cyclosporins
Other Study ID Numbers
- CRAD001AIT02E1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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