Planned Conversion From TAC to SRL-based Regimen in de Novo Kidney Transplant Recipients

H

Helio Tedesco Silva Junior

Status and phase

Completed
Phase 4

Conditions

Kidney Transplant

Treatments

Drug: Conversion from Tacrolimus to Sirolimus
Drug: Maintenance on tacrolimus

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01802268
0468E8-3328

Details and patient eligibility

About

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.

Enrollment

320 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

320 participants in 2 patient groups

Sirolimus
Active Comparator group
Description:
Conversion from Tacrolimus to Sirolimus
Treatment:
Drug: Conversion from Tacrolimus to Sirolimus
Tacrolimus
Active Comparator group
Description:
Maintenance on tacrolimus
Treatment:
Drug: Maintenance on tacrolimus

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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