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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01802268

Enrollment

320

Registered

2013-03-01

Start date

2008-02-29

Completion date

2012-10-31

Last updated

2013-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant

Keywords

sirolimus, tacrolimus, early conversion

Brief summary

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.

Interventions

DRUGConversion from Tacrolimus to Sirolimus

DRUGMaintenance on tacrolimus

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Renal Function calculated using the 4 variable MDRD formula	24 months

Secondary

Measure	Time frame
Incidence of all treated acute rejections.	24 months
Incidence and severity of all tBCAR.	24 months
Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.	24 months
Incidence of treatment discontinuation	24 months
Incidence of adverse events.	24 months
Patient and graft survival.	24 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026