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Completed

NCT Number: NCT01802268

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

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.

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital University Evangélico de Curitiba, Curitiba, Parana, Brazil, Curitiba, Paraná, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conversion from Tacrolimus to Sirolimus

Drug

Maintenance on tacrolimus

Drug

Primary outcomes

  1. Renal Function calculated using the 4 variable MDRD formula

    Time frame: 24 months

Secondary outcomes

  1. Survival free from first treated biopsy confirmed acute rejection episodes (tBCAR) > IA according to Banff 1997 classification.

    Time frame: 24 months

  2. Incidence of all treated acute rejections.

    Time frame: 24 months

  3. Incidence and severity of all tBCAR.

    Time frame: 24 months

  4. Patient and graft survival.

    Time frame: 24 months

  5. Incidence of treatment discontinuation

    Time frame: 24 months

  6. Incidence of adverse events.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Helio Tedesco Silva Junior

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Mar 1, 2013
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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