Study of Everolimus in de Novo Renal Transplant Recipients

Helady Pinheiro, MD, PhD

Status: Terminated

Conditions: End Stage Renal Failure With Renal Transplant

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01609673

CRAD001ABR22T

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Control

No Intervention group

Description:

35 patients using Cyclosporin or Tacrolimus (C0=100-200/5-10ng/mL)+ Myfortic® 1440mg/dia + Steroids. Medications will be administered orally, twice a day

Intervention

Active Comparator group

Description:

35 randomized Patients Converted to Certican® (Everolimus C0=6-10 ng/mL) + Myfortic® 1440mg/day + Steroids. 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.

Treatment:

Drug: Everolimus