Study of Everolimus in de Novo Renal Transplant Recipients

Helady Pinheiro, MD, PhD1 enrolled

Overview

In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes. The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End Stage Renal Failure With Renal Transplant

Interventions

EverolimusDRUG

On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%. In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Renal transplant patients * Age between 18 and 85 years * Recipients of living or deceased donors * Donor under the age of 85 years * Panel Reactivity Antibodies (PRA) over or equal to 30% * 4-5 months post-transplant * CNI-based immunosuppressive regimen * Stable graft function (creatinine lower than 2.0 mg/dl) * No currently acute rejection * Proteinuria lower than 800mg/d * No laboratory or physical clinically significant signs presented for the last 2 months before screening. Exclusion Criteria: * Recipient of multiple organs * Recipient with a history of focal segmental glomerulosclerosis or membranous glomerulonephritis * Presence of uncontrolled hypercholesterolemia (≥350 mg/dL)hypertriglyceridemia (over or equal to 500 mg/dL) * Patients with eGFR lower than 40 ml/min/1.73m2 * Evidence of acute rejection within 2 months before screening * Thrombocytopenia (lower than 75,000/mm3) * Neutropenia (lower than 1,500/mm3) * Leukocytopenia (lower than 2500/mm3) * Anemia (hemoglobin lower than 6.0g/dL) * Severe liver disease (including transaminases or bilirubin equal or over 3 times normal) * Proteinuria over 800mg/dL * Systemic infection or pneumonia (active infection) * Positive for Hepatitis B, Hepatitis C or HIV.

Locations (4)

Hospital São João de Deus/Fundação Geraldo Corrêa

Divinópolis, Minas Gerais, Brazil

Hospital Márcio Cunha/Fundação São Francisco Xavier

Ipatinga, Minas Gerais, Brazil

Fundação IMEPEN

Juiz de Fora, Minas Gerais, Brazil

Hospital do Rim de MOntes Claros/Irmandade Nossa Senhora das Mercês

Montes Claros, Minas Gerais, Brazil

Outcomes

Primary Outcomes

Change in estimated glomerular filtration rate (eGFR)

The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC).

Time frame: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus

Secondary Outcomes

graft acute rejection

incidence of acute biopsy-proven rejection and clinical acute rejection (without biopsy), graft loss, death with a functioning graft, and loss of follow up at 6 and 12 months after conversion;

Time frame: 6 and 12 months after conversion

Laboratory results and clinical alterations

analyzing the incidence of anemia, thrombocytopenia, leukopenia, gastrointestinal side effects, pneumonitis, oral ulcers, edema, proteinuria, and any other adverse events, as well as the need of drug withdrawal

Time frame: 3, 6 and 12 months after conversion

Data from ClinicalTrials.gov

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