NCT03468478

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,209

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2021

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 24, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

March 9, 2018

Results QC Date

November 4, 2022

Last Update Submit

April 20, 2023

Conditions

Kidney Transplant Infection

Outcome Measures

Primary Outcomes (1)

  • Incidence of Cytomegalovirus Infection or Disease

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

    12 months follow up

Study Arms (3)

sirolimus +tacrolimus

EXPERIMENTAL

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

everolimus +tacrolimus

EXPERIMENTAL

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

mycophenolate +tacrolimus

ACTIVE COMPARATOR

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

Interventions

SirolimusDRUG

sirolimus combined to reduced dose of tacrolimus

Also known as: Rapamune
sirolimus +tacrolimus
EverolimusDRUG

everolimus combined to reduced dose of tacrolimus

Also known as: Certican
everolimus +tacrolimus
Mycophenolic acidDRUG

Control arm: mycophenolate combined to regular tacrolimus

Also known as: mycophenolate sodium
mycophenolate +tacrolimus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Rim

São Paulo, São Paulo, 04038002, Brazil

Location

Related Publications (1)

  • Toniato de Rezende Freschi J, Cristelli MP, Viana LA, Ficher KN, Nakamura MR, Proenca H, Dreige YC, de Marco R, de Lima MG, Foresto RD, Aguiar WF, Medina-Pestana J, Tedesco-Silva H. A Head-to-head Comparison of De Novo Sirolimus or Everolimus Plus Reduced-dose Tacrolimus in Kidney Transplant Recipients: A Prospective and Randomized Trial. Transplantation. 2024 Jan 1;108(1):261-275. doi: 10.1097/TP.0000000000004749. Epub 2023 Aug 1.

    PMID: 37525373DERIVED

MeSH Terms

Interventions

SirolimusEverolimusMycophenolic Acid

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipids

Results Point of Contact

Title
Dr. Helio Tedesco Silva Junior
Organization
Hospital do Rim - Fundação Oswaldo Ramos
heliotedesco@medfarm.com.br
55 11 50878113

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 16, 2018

Study Start

June 18, 2017

Primary Completion

March 18, 2021

Study Completion

August 23, 2021

Last Updated

April 24, 2023

Results First Posted

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)