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OpenTrials
Completed

NCT Number: NCT03468478

Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.

The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital do Rim

São Paulo, 04038002, Brazil

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Recipients, adults of the first living or deceased donor kidney transplant;
  • Patients who agreed to participate in the study and signed the informed consent form

Exclusion criteria

  • Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;
  • Receptors with poor understanding about chronic kidney disease and its treatment alternatives;
  • Receptors with early history of non compliance to treatment with immunosuppressive drugs;
  • Retransplantation;
  • Multi-organ recipients;
  • Recipients with BMI> 30 kg / m2;
  • KDPI> 80%;
  • Cold ischemia time greater than 24 hours;
  • Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;
  • Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).
  • Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;
  • Patients with severe uncontrolled dyslipidemia;
  • Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;

Treatment and study plan

sirolimus

Drug

sirolimus combined to reduced dose of tacrolimus

Other names: Rapamune

Everolimus

Drug

everolimus combined to reduced dose of tacrolimus

Other names: Certican

Mycophenolic Acid

Drug

Control arm: mycophenolate combined to regular tacrolimus

Other names: mycophenolate sodium

Primary outcomes

  1. Incidence of Cytomegalovirus Infection or Disease

    Time frame: 12 months follow up

    Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS).

Sponsors and collaborators

Lead sponsor

Hospital do Rim e Hipertensão

Other

Registry information

Official study title

Comparison of the Efficacy and Safety of Sirolimus, Everolimus or Mycophenolate in Renal Transplant Recipients Receiving Induction With Anti-thymocyte Globulin, Tacrolimus and Prednisone

Acronym: SEM

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2018
Registry last updated
Apr 24, 2023

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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