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

Sponsor
Hospital do Rim e Hipertensão (Other)
Overall Status
Completed
CT.gov ID
NCT03468478
Collaborator
(none)
319
Enrollment
1
Location
3
Arms
50.2
Actual Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
319 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Jun 18, 2017
Actual Primary Completion Date :
Mar 18, 2021
Actual Study Completion Date :
Aug 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: sirolimus +tacrolimus

Patients will receive initial dose of 0,05 mg/kg BID oftacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of sirolimus of 3mg once a day to reach blood trough concentration between 4-8 ng/mL.

Drug: Sirolimus
sirolimus combined to reduced dose of tacrolimus
Other Names:
  • Rapamune

    		•
    Experimental: everolimus +tacrolimus

    Patients will receive initial dose of 0,05 mg/kg BID de tacrolimus to reach blood trough concentration between 3-5 ng/mL. Initial dose of 1.5 mg BID of everolimus to reach blood trough concentration between 4-8 ng/mL.

    Drug: Everolimus
    everolimus combined to reduced dose of tacrolimus
    Other Names:
  • Certican

    		•
    Active Comparator: mycophenolate +tacrolimus

    Patients will receive initial dose of 0,1 mg/kg BID de tacrolimusto reach blood trough concentration between Fixed dose of mycophenolate (mycophenolate mofetil, 1 g BID or sodium mycophenolate, 720 mg BID).

    Drug: Mycophenolic acid
    Control arm: mycophenolate combined to regular tacrolimus
    Other Names:
  • mycophenolate sodium

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of cytomegalovirus infection or disease [12 months follow up]

      treatment of cytomegalovirus infection or disease within 12 months after kidney transplantation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Recipients, adults of the first living or deceased donor kidney transplant;

    2. Patients who agreed to participate in the study and signed the informed consent form

    Exclusion Criteria:

    1. Receptors with a medical history of nephrotic syndrome or focal and segmental glomerulosclerosis confirmed as the etiology of end-stage renal disease;

    2. Receptors with poor understanding about chronic kidney disease and its treatment alternatives;

    3. Receptors with early history of non compliance to treatment with immunosuppressive drugs;

    4. Retransplantation;

    5. Multi-organ recipients;

    6. Recipients with BMI> 30 kg / m2;

    7. KDPI> 80%;

    8. Cold ischemia time greater than 24 hours;

    9. Receptors with a percentage of anti-HLA antibodies above 50%, either class I or Class II;

    10. Women of childbearing potential who do not undertake contraceptive methods (condoms or oral contraceptives).

    11. Patients receiving immunosuppressive therapy prior to transplantation, except low dose of prednisone;

    12. Patients with severe uncontrolled dyslipidemia;

    13. Patients who have a known contraindication for administration of any of the immunosuppressive drugs provided for in this study;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital do Rim São Paulo Sao Paulo Brazil 04038002

    Sponsors and Collaborators

    • Hospital do Rim e Hipertensão

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Helio Tedesco Silva Junior, Principal Investigator, Hospital do Rim e Hipertensão
    ClinicalTrials.gov Identifier:
    NCT03468478
    Other Study ID Numbers:
    • HRHipertensao
    First Posted:
    Mar 16, 2018
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Mycophenolic Acid
    Sirolimus
    Everolimus

    Study Results

    No Results Posted as of Aug 27, 2021