Study of Everolimus in de Novo Renal Transplant Recipients

• Status: Terminated
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helady Pinheiro, MD, PhD
• Collaborator: Novartis
• Treatments: Calcineurin Inhibitors; Everolimus; Sirolimus

Criteria

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.