Trial | NCT01609673  Report issue

Title

Study of Everolimus in de Novo Renal Transplant Recipients
Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    everolimus ...

  • Study Participants

    1
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 Started
Mar 31
2013
Primary Completion
May 31
2013
Study Completion
May 31
2013
Last Update
Jun 12
2013
Estimate

Drug Everolimus

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.

  • Other names: Certican

Control No Intervention

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

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.

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.
No Results Posted