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Completed

NCT Number: NCT01276457

Everolimus in Combination With Cyclosporine Microemulsion 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.

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Key information

Conditions

Transplantation Infection

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Everolimus 0.25 and 0.75 mg tablets

Drug

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.

Cyclosporine very low dose (150-300 ng/mL) microemulsion

Drug

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: Neoral

Cyclosporine low dose (350-500 ng/mL) microemulsion

Drug

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: Neoral

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: EVEREST

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 13, 2011
Registry last updated
May 20, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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