Trial | NCT01802268  Report issue

Title

Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients
Outcomes of Planned Conversion From Tacrolimus to Sirolimus-based Immunosuppressive Regimen in de Novo Kidney Transplant Recipients

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tacrolimus sirolimus ...

  • Study Participants

    320
Background Early conversion from calcineurin inhibitor to mammalian target of rapamycin inhibitor is one of the immunosuppressive strategies that have been investigated to mitigate long-term CNi associated adverse events. This study aims to evaluate the conversion from tacrolimus to sirolimus in de novo kidney transplant recipients.

This multicenter, open-label study, planned to enroll 297 patients initially treated with tacrolimus, enteric-coated mycophenolate sodium (1440 mg/day, orally) and prednisone. The primary objective is to show superior glomerular filtration rate in the SRL group at 24 months after transplantation.
Study Started
Feb 29
2008
Primary Completion
Apr 30
2012
Study Completion
Oct 31
2012
Last Update
Mar 01
2013
Estimate

Drug Conversion from Tacrolimus to Sirolimus

Drug Maintenance on tacrolimus

Sirolimus Active Comparator

Conversion from Tacrolimus to Sirolimus

Tacrolimus Active Comparator

Maintenance on tacrolimus

Criteria 

Inclusion Criteria:

patients older than 18 years,
recipients of first kidney transplant from brain dead deceased or living related non-HLA identical donors not older than 65 years,
patients had to receive an ABO compatible organ with a CDC negative crossmatch and a peak panel reactive antibody lower that 30%,
all patients agreed to use contraceptive methods during the study and up to 3 months after study drug discontinuation.

Exclusion Criteria:

patients with chronic kidney diseases due to focal and segmental glomerulosclerosis and membranoproliferative glomerulonephritis,
patients with active infection or positive for hepatitis B or C or human immunodeficiency viruses,
patients with previous history of malignancy,
patients with significant hematological or metabolic laboratorial abnormalities.
No Results Posted