Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients

Novartis Pharmaceuticals223 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

223

Conditions

Transplantation Infection

Interventions

Everolimus 0.25 and 0.75 mg tabletsDRUG

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) microemulsionDRUG

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.

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants With Biopsy-proven Acute Rejection

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.

Time frame: Baseline to end of study (Month 24)

Renal Function Assessed by Creatinine Clearance

Renal function was assessed by measuring serum creatinine and by computing creatinine clearance using the formula of Cockcroft-Gault.

Time frame: Month 12, Month 18, and Month 24

Secondary Outcomes

Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft

A participant lost his graft if he/she started dialysis and was not able to subsequently be removed from dialysis or underwent graft nephrectomy.

Time frame: Baseline to end of study (Month 24)

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths

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.

Time frame: Baseline to end of study (Month 24)

Data from ClinicalTrials.gov

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